Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-28 @ 3:37 PM
Study NCT ID:
NCT02980705
Status:
TERMINATED
Last Update Posted:
2021-11-01
First Post:
2016-11-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of SUNPG1622
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089202', 'term': 'Non-Radiographic Axial Spondyloarthritis'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@sparcmail.com', 'phone': '912266455645', 'title': 'Dr Mudgal Kothekar', 'organization': 'Sun Pharma Advanced Research Company Limited'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 72', 'description': 'It is the approximate duration over which adverse event data were collected.\n\nAnalysis of adverse events was performed in 3 Parts:\n\nPart 1: SUNPG1622→Placebo; from Day 1 to Week 24 Part 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52 Part 3: Washout period between Week 52 and Week 72. In Part 3 of the study, all subjects underwent IMP washout and no subjects received SUNPG1622.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: SUNPG1622 or Placebo', 'description': 'Group 1: SUNPG1622 or Placebo; From Baseline to Week 24.\n\nSafety results are provided per the following:\n\nGroup 1: Subjects recieved either SUNPG1622 or Placebo', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 12, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 2: Treatment Follow-up (SUNPG16221 Dose Injection)', 'description': 'Group 2: Treatment follow-up (SUNPG16221 dose injection); from Week 24 to Week 52.\n\nSafety results are provided per the following:\n\nGroup 2: Subjects recieved SUNPG1622', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 13, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 3: Washout', 'description': 'Group 3: Washout period between Week 52 and Week 72.\n\nSafety results are provided per the following:\n\nGroup 3: washout period', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site joint erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of SpondyloArthritis International Society 20 Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1622 I', 'description': 'SUNPG1622 I dose: Injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose: Injection'}], 'classes': [{'categories': [{'measurements': [{'value': '74.00', 'groupId': 'OG000'}, {'value': '80.39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 \\[no disease activity\\]-100 \\[high disease activity\\]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates at Week 24 by Cohort (Full Analysis Set)'}, {'type': 'SECONDARY', 'title': 'Assessment of SpondyloArthritis International Society 20 Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SUNPG1622 I', 'description': 'SUNPG1622 I dose: Injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose: Injection'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '74.00', 'groupId': 'OG000'}, {'value': '83.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '68.00', 'groupId': 'OG000'}, {'value': '59.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '64.00', 'groupId': 'OG000'}, {'value': '57.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '50.00', 'groupId': 'OG000'}, {'value': '46.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '40.00', 'groupId': 'OG000'}, {'value': '36.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '30.00', 'groupId': 'OG000'}, {'value': '22.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '16.33', 'groupId': 'OG000'}, {'value': '20.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24', 'description': 'Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 \\[no disease activity\\]-100 \\[high disease activity\\]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ASAS20 Response Rates up to Week 24 by Cohort (Full Analysis Set)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SUNPG1622 I', 'description': 'SUNPG1622 I dose: Injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo dose: Injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'withdrew participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'It was planned that 90 subjects with active AS and 90 subjects with nr-axSpA would be enrolled to ensure completion of 180 subjects. One hundred and one subjects with active AS were actually enrolled and randomized and 82 subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SUNPG1622 I', 'description': 'SUNPG1622 I dose: Injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo dose: Injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age, mean years (SD)', 'categories': [{'measurements': [{'value': '39.8', 'spread': '9.18', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '11.00', 'groupId': 'BG001'}, {'value': '39.5', 'spread': '10.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-14', 'size': 1344675, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-16T05:21', 'hasProtocol': True}, {'date': '2019-10-01', 'size': 2350543, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-19T01:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'whyStopped': "Study terminated-Sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2016-11-30', 'resultsFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-12', 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of SpondyloArthritis International Society 20 Response Rates', 'timeFrame': 'Week 24', 'description': 'Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 \\[no disease activity\\]-100 \\[high disease activity\\]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set).'}], 'secondaryOutcomes': [{'measure': 'Assessment of SpondyloArthritis International Society 20 Response Rates', 'timeFrame': 'Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24', 'description': 'Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 \\[no disease activity\\]-100 \\[high disease activity\\]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '37162744', 'type': 'DERIVED', 'citation': 'Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients With Active Ankylosing Spondylitis. J Clin Rheumatol. 2023 Aug 1;29(5):223-229. doi: 10.1097/RHU.0000000000001973. Epub 2023 May 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has provided informed written consent\n* Subject is ≥ 18 years of age at time of Screening\n* Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product\n* Subject has a negative test for TB within 4 weeks before initiating IMP\n\nExclusion Criteria:\n\n* Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes\n* Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening\n* Radiographic evidence of total ankylosis of the spine\n* Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition'}, 'identificationModule': {'nctId': 'NCT02980705', 'briefTitle': 'Efficacy and Safety Study of SUNPG1622', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis', 'orgStudyIdInfo': {'id': 'CLR_16_22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUNPG1622 I', 'description': 'SUNPG1622 I dose', 'interventionNames': ['Drug: SUNPG1622 I dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo dose', 'interventionNames': ['Drug: Placebo dose']}], 'interventions': [{'name': 'SUNPG1622 I dose', 'type': 'DRUG', 'description': 'Injection', 'armGroupLabels': ['SUNPG1622 I']}, {'name': 'Placebo dose', 'type': 'DRUG', 'description': 'Injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'SPARC Site 1', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'SPARC site 3', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Elblag', 'country': 'Poland', 'facility': 'SPARC site 3', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'SPARC site 2', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}