Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
Study NCT ID:
NCT04518995
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2020-08-16
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D006201', 'term': 'Hair Diseases'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AAclinicaltrial_inquiries@concertpharma.com', 'phone': '781-860-0045', 'title': 'Colleen E. Hamilton', 'organization': 'Concert Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)', 'description': 'All-cause mortality: All randomized participants included all participants who were randomized in the study.\n\nAdverse events: Safety population included all participants who received study drug during the treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 31, 'seriousNumAtRisk': 140, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.', 'otherNumAtRisk': 350, 'deathsNumAtRisk': 351, 'otherNumAffected': 117, 'seriousNumAtRisk': 350, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 75, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood creatine phosphokinase (increased)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Adjustment disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 350, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}, {'value': '41.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.33', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.026', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.32', 'ciUpperLimit': '0.46', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '46.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}, {'value': '51.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '37.4', 'groupId': 'OG001'}, {'value': '54.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '42.1', 'groupId': 'OG001'}, {'value': '53.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.32', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.038', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.43', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.044', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.38', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.035', 'groupDescription': 'Week 16', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.041', 'groupDescription': 'Week 16', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.39', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'groupDescription': 'Week 20', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.55', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.040', 'groupDescription': 'Week 20', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.44', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'groupDescription': 'Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.55', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.039', 'groupDescription': 'Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': 'SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Responders were defined as participants with responses of "satisfied" or "very satisfied".', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}, {'value': '18.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}, {'value': '29.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}, {'value': '37.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.02', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.005', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.05', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.010', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.09', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'groupDescription': 'Week 8', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.14', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.018', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.22', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.027', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.19', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 16', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.33', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'groupDescription': 'Week 16', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.28', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'groupDescription': 'Week 20', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.41', 'pValueComment': 'P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.034', 'groupDescription': 'Week 20', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, and 20', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Relative Change From Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '12.79', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '12.03', 'groupId': 'OG002'}]}]}, {'title': 'Relative Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '11.41', 'groupId': 'OG000'}, {'value': '-10.9', 'spread': '21.00', 'groupId': 'OG001'}, {'value': '17.5', 'spread': '27.16', 'groupId': 'OG002'}]}]}, {'title': 'Relative Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '16.63', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '29.45', 'groupId': 'OG001'}, {'value': '-31.1', 'spread': '35.53', 'groupId': 'OG002'}]}]}, {'title': 'Relative Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '21.06', 'groupId': 'OG000'}, {'value': '-30.3', 'spread': '34.20', 'groupId': 'OG001'}, {'value': '-41.2', 'spread': '38.95', 'groupId': 'OG002'}]}]}, {'title': 'Relative Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '22.14', 'groupId': 'OG000'}, {'value': '-36.0', 'spread': '37.82', 'groupId': 'OG001'}, {'value': '-46.8', 'spread': '41.32', 'groupId': 'OG002'}]}]}, {'title': 'Relative Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '23.30', 'groupId': 'OG000'}, {'value': '-41.2', 'spread': '39.37', 'groupId': 'OG001'}, {'value': '-50.4', 'spread': '41.52', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0564', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '0.1', 'pValueComment': 'P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.13', 'groupDescription': 'Week 4', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0054', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.23', 'groupDescription': 'Week 4', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '-4.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.16', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.9', 'ciLowerLimit': '-19.5', 'ciUpperLimit': '-10.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.34', 'groupDescription': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.7', 'ciLowerLimit': '-27.5', 'ciUpperLimit': '-16.0', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.94', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.0', 'ciLowerLimit': '-36.3', 'ciUpperLimit': '-23.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.19', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.4', 'ciLowerLimit': '-35.1', 'ciUpperLimit': '-21.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.38', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.5', 'ciLowerLimit': '-45.7', 'ciUpperLimit': '-31.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.66', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.9', 'ciLowerLimit': '-42.1', 'ciUpperLimit': '-27.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.66', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.6', 'ciLowerLimit': '-52.3', 'ciUpperLimit': '-36.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.96', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.3', 'ciLowerLimit': '-46.7', 'ciUpperLimit': '-31.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.79', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.0', 'ciLowerLimit': '-55.1', 'ciUpperLimit': '-39.0', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.10', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\\[post-baseline SALT score - baseline SALT score\\]/baseline SALT score).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}, {'value': '43.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}, {'value': '54.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '59.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 16', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 16', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).", 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}, {'value': '49.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '56.6', 'groupId': 'OG001'}, {'value': '65.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 16', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 16', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.', 'groupDescription': 'Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': 'The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '0.76', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.53', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.77', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '1.92', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.03', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-0.9', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.9', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-1.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-1.2', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-1.6', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-1.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': "The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.79', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '1.95', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '2.07', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.3', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.6', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-0.9', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-1.4', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-1.5', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-1.3', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-1.8', 'pValueComment': 'P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': '75% Relative Reduction: Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '17.7', 'groupId': 'OG002'}]}]}, {'title': '75% Relative Reduction: Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}, {'title': '90% Relative Reduction: Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}, {'title': '90% Relative Reduction: Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}, {'value': '32.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.12', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.016', 'groupDescription': '75% Relative Reduction: Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.22', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.026', 'groupDescription': '75% Relative Reduction: Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.33', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.025', 'groupDescription': '75% Relative Reduction: Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.32', 'ciUpperLimit': '0.45', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.033', 'groupDescription': '75% Relative Reduction: Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.06', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.010', 'groupDescription': '90% Relative Reduction: Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.14', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'groupDescription': '90% Relative Reduction: Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.23', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'groupDescription': '90% Relative Reduction: Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.37', 'pValueComment': 'P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'groupDescription': '90% Relative Reduction: Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 12, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.91', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '2.05', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.2', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.6', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.2', 'ciUpperLimit': '2.2', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.4', 'ciUpperLimit': '2.4', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, and 24', 'description': 'BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0 = no eyebrow, 1 = minimal eyebrow, 2 = moderate eyebrow, 3 = normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.10', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.08', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.99', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '2.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.0', 'ciUpperLimit': '2.0', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.4', 'ciUpperLimit': '2.4', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, and 24', 'description': 'BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.85', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '1.43', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '1.52', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.64', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-1.1', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-1.2', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-1.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '44.7', 'groupId': 'OG001'}, {'value': '53.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '48.1', 'groupId': 'OG001'}, {'value': '53.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}, {'value': '57.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '49.1', 'groupId': 'OG001'}, {'value': '58.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.34', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.044', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.42', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.049', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.42', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.040', 'groupDescription': 'Week 16', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.30', 'ciUpperLimit': '0.48', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.045', 'groupDescription': 'Week 16', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.42', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.040', 'groupDescription': 'Week 20', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.045', 'groupDescription': 'Week 20', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.29', 'ciUpperLimit': '0.44', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.039', 'groupDescription': 'Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.53', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.045', 'groupDescription': 'Week 24', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': 'SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Satisfied Thickness Hair Coverage: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.76', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.17', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Thickness Hair Coverage: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.68', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.16', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '1.40', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied Evenness Hair Coverage: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '1.52', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '1.35', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.27', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.32', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyebrows: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.36', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.30', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': 'How Satisfied With Your Eyelashes: Change From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.6', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '-1.1', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-1.2', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Satisfied Thickness Hair Coverage: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.4', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-1.0', 'pValueComment': 'P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'Satisfied Evenness Hair Coverage: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.6', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.9', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.9', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.8', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.9', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyebrows: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.3', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.4', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 16', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.5', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 20', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.6', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.7', 'pValueComment': 'P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'How Satisfied With Your Eyelashes: Week 24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'title': 'Anxiety: Baseline', 'categories': [{'measurements': [{'value': '5.5', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '4.06', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '3.92', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety: Change From Baseline at Week 24', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '3.24', 'groupId': 'OG002'}]}]}, {'title': 'Depression: Baseline', 'categories': [{'measurements': [{'value': '3.3', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '3.31', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '3.39', 'groupId': 'OG002'}]}]}, {'title': 'Depression: Change From Baseline at Week 24', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.93', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '2.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2489', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.9', 'pValueComment': 'P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Anxiety', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1235', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '1.1', 'pValueComment': 'P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'Anxiety', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9765', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'pValueComment': 'P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Depression', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3559', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.8', 'pValueComment': 'P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Depression', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \\>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'OG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}, {'value': '34.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.25', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.39', 'pValueComment': 'P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.'}, {'id': 'FG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'FG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '351'}, {'groupId': 'FG002', 'numSubjects': '215'}]}, {'type': 'Efficacy Population', 'comment': 'Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '351'}, {'groupId': 'FG002', 'numSubjects': '215'}]}, {'type': 'Safety Population', 'comment': 'Safety population included all participants who received study drug during the treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '350'}, {'groupId': 'FG002', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '318'}, {'groupId': 'FG002', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Treatment Emergent or Worsening Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study centers in Canada, France, Poland, Spain and the United States from 23 November 2020 to 19 April 2022.', 'preAssignmentDetails': '946 participants were screened, out of which 706 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '706', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks.'}, {'id': 'BG001', 'title': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'BG002', 'title': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '13.81', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '13.32', 'groupId': 'BG001'}, {'value': '38.2', 'spread': '12.80', 'groupId': 'BG002'}, {'value': '38.6', 'spread': '13.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '437', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '599', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants included all participants who were randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-28', 'size': 4124497, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-13T04:45', 'hasProtocol': True}, {'date': '2022-04-15', 'size': 887353, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-13T04:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 706}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-07', 'studyFirstSubmitDate': '2020-08-16', 'resultsFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2020-08-16', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-07', 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score of ≤20 at Week 24', 'timeFrame': 'Week 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': 'SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Responders were defined as participants with responses of "satisfied" or "very satisfied".'}, {'measure': 'Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20', 'timeFrame': 'Weeks 4, 8, 12, 16, and 20', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).'}, {'measure': 'Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\\[post-baseline SALT score - baseline SALT score\\]/baseline SALT score).'}, {'measure': 'Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': "The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved)."}, {'measure': 'Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': 'The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).'}, {'measure': 'Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': "The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss."}, {'measure': 'Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.'}, {'measure': 'Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24', 'timeFrame': 'Baseline, Weeks 12, and 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.'}, {'measure': 'Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24', 'timeFrame': 'Baseline, Weeks 12, and 24', 'description': 'BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0 = no eyebrow, 1 = minimal eyebrow, 2 = moderate eyebrow, 3 = normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.'}, {'measure': 'Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24', 'timeFrame': 'Baseline, Weeks 12, and 24', 'description': 'BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.'}, {'measure': 'Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.'}, {'measure': 'Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24', 'timeFrame': 'Weeks 12, 16, 20, and 24', 'description': 'SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied.'}, {'measure': 'Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24', 'timeFrame': 'Baseline, Weeks 12, 16, 20, and 24', 'description': 'The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.'}, {'measure': 'Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HADS is a questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and \\>14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.'}, {'measure': 'Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24', 'timeFrame': 'Week 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alopecia', 'Hair loss', 'Hair disease', 'CTP-543'], 'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.\n* At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.\n* Willing to comply with the study visits and requirements of the study protocol.\n\nExclusion Criteria:\n\n* Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.\n* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.\n* Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.\n* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.\n* Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.'}, 'identificationModule': {'nctId': 'NCT04518995', 'acronym': 'THRIVE-AA1', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concert Pharmaceuticals'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)', 'orgStudyIdInfo': {'id': 'CP543.3001'}, 'secondaryIdInfos': [{'id': '2020-002704-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543 matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CTP-543 8 mg BID', 'description': 'Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CTP-543 12 mg BID', 'description': 'Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.', 'interventionNames': ['Drug: CTP-543']}], 'interventions': [{'name': 'CTP-543 matching placebo', 'type': 'DRUG', 'description': 'Administered as tablets.', 'armGroupLabels': ['Placebo']}, {'name': 'CTP-543', 'type': 'DRUG', 'description': 'Administered as tablets.', 'armGroupLabels': ['CTP-543 8 mg BID']}, {'name': 'CTP-543', 'type': 'DRUG', 'description': 'Administered as tablets.', 'armGroupLabels': ['CTP-543 12 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 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