Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-28 @ 7:25 PM
Study NCT ID:
NCT02447302
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656249', 'term': 'etrasimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ct.gov@arenapharm.com', 'phone': '+1 855-218-9153', 'title': 'Arena CT.gov Administrator', 'organization': 'Arena Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 16 weeks i.e. from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug.', 'description': 'Treatment-Emergent Adverse Event (TEAE) were collected during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 11, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 11, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 9, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Adapted Mayo Score (MCS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.94', 'groupId': 'OG000', 'lowerLimit': '-2.45', 'upperLimit': '-1.42'}, {'value': '-2.49', 'groupId': 'OG001', 'lowerLimit': '-3.01', 'upperLimit': '-1.98'}, {'value': '-1.50', 'groupId': 'OG002', 'lowerLimit': '-2.00', 'upperLimit': '-1.01'}]}]}], 'analyses': [{'pValue': '= 0.0091', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.99', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '-0.30', 'pValueComment': 'The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'estimateComment': 'Estimated least square mean difference in etrasimod 2 mg from placebo', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.'}, {'pValue': '= 0.1457', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.43', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.24', 'pValueComment': 'The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'estimateComment': 'Estimated least square mean difference in etrasimod 1 mg from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Endoscopic Improvement at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}, {'value': '17.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'MH estimate for difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '24.4', 'ciLowerLimit': '9.8', 'ciUpperLimit': '39.0', 'pValueComment': 'Mantel-Haenszel (MH) estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.87', 'estimateComment': 'MH estimated difference in etrasimod 2 mg from Placebo', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.'}, {'pValue': '= 0.3059', 'groupIds': ['OG000', 'OG002'], 'paramType': 'MH estimate for difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.1', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '17.2', 'pValueComment': 'MH estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.98', 'estimateComment': 'MH estimated difference in etrasimod 1 mg from Placebo', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-component MCS at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.30', 'groupId': 'OG000', 'lowerLimit': '-1.66', 'upperLimit': '-0.95'}, {'value': '-1.75', 'groupId': 'OG001', 'lowerLimit': '-2.11', 'upperLimit': '-1.40'}, {'value': '-0.92', 'groupId': 'OG002', 'lowerLimit': '-1.26', 'upperLimit': '-0.57'}]}]}], 'analyses': [{'pValue': '= 0.0020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.84', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.36', 'pValueComment': 'The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'estimateComment': 'Estimated least square mean difference in etrasimod 2 mg from placebo', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.'}, {'pValue': '= 0.0858', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.39', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.08', 'pValueComment': 'The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'estimateComment': 'Estimated least square mean difference in etrasimod 1 mg from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Mayo Score (TMS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.69', 'groupId': 'OG000', 'lowerLimit': '-3.36', 'upperLimit': '-2.02'}, {'value': '-3.35', 'groupId': 'OG001', 'lowerLimit': '-4.03', 'upperLimit': '-2.68'}, {'value': '-2.08', 'groupId': 'OG002', 'lowerLimit': '-2.73', 'upperLimit': '-1.44'}]}]}], 'analyses': [{'pValue': '= 0.0100', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.27', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '-0.37', 'pValueComment': 'The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'estimateComment': 'Estimated least square mean difference in etrasimod 2 mg from placebo', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.'}, {'pValue': '= 0.1277', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least square mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.60', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '0.27', 'pValueComment': 'The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'estimateComment': 'Estimated least square mean difference in etrasimod 1 mg from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores \\[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0071', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.78', 'ciLowerLimit': '1.40', 'ciUpperLimit': '5.51', 'pValueComment': 'The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.'}, {'pValue': '= 0.1192', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.61', 'ciLowerLimit': '0.83', 'ciUpperLimit': '3.14', 'pValueComment': 'The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Achieved Clinical Remission at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '33.0', 'groupId': 'OG001'}, {'value': '8.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'MH estimate for difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '25.8', 'ciLowerLimit': '13.5', 'ciUpperLimit': '38.1', 'pValueComment': 'The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.47', 'estimateComment': 'MH estimated difference in etrasimod 2 mg from Placebo', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.'}, {'pValue': '= 0.1360', 'groupIds': ['OG000', 'OG002'], 'paramType': 'MH estimate for difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.1', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '17.7', 'pValueComment': 'The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.46', 'estimateComment': 'MH estimated difference in etrasimod 1 mg from Placebo', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Achieved Clinical Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '32.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0282', 'groupIds': ['OG001', 'OG002'], 'paramType': 'MH estimate for difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '18.9', 'ciLowerLimit': '2.6', 'ciUpperLimit': '35.3', 'pValueComment': 'The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.92', 'estimateComment': 'MH estimated difference in etrasimod 2 mg from Placebo', 'groupDescription': 'The primary comparison in the study was between etrasimod 2 mg versus placebo.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.'}, {'pValue': '= 0.1309', 'groupIds': ['OG000', 'OG002'], 'paramType': 'MH estimate for difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.4', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '28.1', 'pValueComment': 'The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.14', 'estimateComment': 'MH estimated difference in etrasimod 1 mg from Placebo', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'FG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study included a screening period (up to 28 days), a double-blind induction treatment period (12 weeks), and a possible follow-up visit (2 weeks after the last study visit). The target population consisted of male or female participants aged between 18 and 80 years (inclusive), with moderately to severely active Ulcerative Colitis.', 'preAssignmentDetails': 'During the screening period (Days -28 to -1), participants were evaluated for study entry based on the inclusion and exclusion criteria. Screening procedures to evaluate participant eligibility for the study were to be conducted within 28 days prior to study drug administration on Day 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Etrasimod 1 mg', 'description': 'Etrasimod 1 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'BG001', 'title': 'Etrasimod 2 mg', 'description': 'Etrasimod 2 mg was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. The study drug was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo was administered orally once daily for 12 weeks, administered with approximately 240 mL (8 ounces) of water. Placebo was to be taken on an empty stomach after an overnight fast of approximately 8 hours.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '64'}, {'value': '38.5', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '67'}, {'value': '46.0', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '73'}, {'value': '42', 'groupId': 'BG003', 'lowerLimit': '20', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Adults (18-64 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}, {'title': 'From 65-80 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Subjects'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Adapted Mayo Score (MCS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.23', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '1.17', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '1.51', 'groupId': 'BG002'}, {'value': '6.5', 'spread': '1.31', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analysis was performed using the intent-to-treat (ITT) population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.'}, {'title': 'The 2-component MCS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.75', 'groupId': 'BG000'}, {'value': '4.2', 'spread': '0.75', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '0.91', 'groupId': 'BG002'}, {'value': '4.2', 'spread': '0.80', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.'}, {'title': 'Total Mayo Score (TMS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.43', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '1.47', 'groupId': 'BG001'}, {'value': '8.7', 'spread': '1.72', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '1.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The TMS consisted of 4 subscores \\[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analysis was performed using the ITT population that consisted of all randomized participants who received at least 1 dose of study drug. One subject had missing data at baseline.'}], 'populationDescription': 'The analysis was performed using the safety population that consisted of all randomized participants who received at least 1 dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-03', 'size': 2651026, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-12T16:59', 'hasProtocol': True}, {'date': '2018-02-27', 'size': 1292366, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-12T17:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2019-02-13', 'completionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2015-05-13', 'dispFirstSubmitQcDate': '2019-02-13', 'resultsFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2015-05-14', 'dispFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-10', 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trichotomous Composite Score of Clinical Remission and Clinical Response at Week 12', 'timeFrame': 'Week 12', 'description': 'The trichotomous composite score of clinical remission and clinical response at Week 12 is an ordinal categorical endpoint with 3 categories (score ranging 0 to 2: score 2 for achieving both clinical remission and clinical response; 1 for only achieving clinical response, and 0 for achieving neither). Multiple imputation method was used to handle missing data.'}, {'measure': 'Percentage of Participants Who Achieved Clinical Remission at Week 12', 'timeFrame': 'Week 12', 'description': 'A participant was considered to have achieved clinical remission if he/she had: 1) an endoscopy score using flexible proctosigmoidoscopy of 0 or 1 (excluding friability), 2) a rectal bleeding score of 0 or 1, and 3) a stool frequency score of 0 or 1 with a decrease of ≥1 point from baseline. Multiple imputation method was used to handle missing data.'}, {'measure': 'Percentage of Participants Who Achieved Clinical Response at Week 12', 'timeFrame': 'Week 12', 'description': 'A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission defined above, or met criteria of clinical response. Clinical response was defined as a decrease in the adapted MCS of ≥ 2 points and a decrease of ≥ 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Adapted Mayo Score (MCS) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Endoscopic Improvement at Week 12', 'timeFrame': 'Week 12', 'description': 'For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.'}, {'measure': 'Change From Baseline in 2-component MCS at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.'}, {'measure': 'Change From Baseline in Total Mayo Score (TMS) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores \\[stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score\\], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '39778975', 'type': 'DERIVED', 'citation': 'Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.'}, {'pmid': '39526078', 'type': 'DERIVED', 'citation': 'Lees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Therap Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.'}, {'pmid': '38245818', 'type': 'DERIVED', 'citation': 'Yarur AJ, Chiorean MV, Panes J, Jairath V, Zhang J, Rabbat CJ, Sandborn WJ, Vermeire S, Peyrin-Biroulet L. Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial. J Crohns Colitis. 2024 Jun 3;18(6):885-894. doi: 10.1093/ecco-jcc/jjae007.'}, {'pmid': '31711921', 'type': 'DERIVED', 'citation': 'Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score\n* Evidence of colonic ulcerative colitis activity on endoscopy\n\nExclusion Criteria:\n\n* Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol\n* Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent\n* Any prior exposure to natalizumab, efalizumab, or rituximab'}, 'identificationModule': {'nctId': 'NCT02447302', 'briefTitle': 'Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arena Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'APD334-003'}, 'secondaryIdInfos': [{'id': '2015-001942-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etrasimod Low Dose', 'description': 'Oral, low dose, daily for 12 Weeks', 'interventionNames': ['Drug: Etrasimod']}, {'type': 'EXPERIMENTAL', 'label': 'Etrasimod High Dose', 'description': 'Oral, high dose, daily for 12 weeks', 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