Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05355805
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hidradenitis Suppurativa Phase 2b Study of Izokibep
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Donald.Betah@acelyrin.com', 'phone': '(805) 419-3805', 'title': 'Donald Betah', 'organization': 'Acelyrin'}, 'certainAgreement': {'otherDetails': "Per Clinical Trial Agreements, sites may not publish study results without sponsor's written consent:\n\n* sponsor has right to first publication\n* after first publication, site may publish if sponsor is given 60 days to review for confidential/proprietary information\n* if publication may impact sponsor rights (eg, a patent), sponsor may request 90-day delay\n* if sponsor does not publish within 12 months after study end or confirms they will not, site may publish, subject to sponsor's rights above", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks.', 'description': 'SAS: all randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 25, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part B Placebo QW/Q2W (Up to Week 16)', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 25, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part B Izokibep 160 mg QW - (Up to Week 16)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 43, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part B Izokibep 160 mg Q2W (Up to Week 16)', 'description': 'Participants received izokibep Q2W in a blinded manor for 16 weeks.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 34, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)', 'description': 'Participants received izokibep Q2W in a blinded manor for weeks 16-30.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 10, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)', 'description': 'Participants received izokibep QW in a blinded manor for weeks 16-31.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 14, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part B: Izokibep 160 mg Q2W (Week 16 to 30)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 9, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: Izokibep 160 mg QW (Week 16 to 31)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 13, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 38, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 59, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 44, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 75, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 53, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 43, 'numEvents': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 23, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 30, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 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'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 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30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Cutaneous vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': "Still's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part A: Baseline to Week 12', 'description': 'HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part A: all participants who received at lease one dose of study drug in Part A.'}, {'type': 'PRIMARY', 'title': 'Part B: Number of Participants Who Achieved HiSCR75 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '8.27', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.075', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR75.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6192', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.19', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.427', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR75.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B.'}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks', 'description': 'An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS): all participants who received at lease one dose of study drug in Part A.'}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 16, Week 32, Week 39', 'description': 'Blood samples were collected at different time points throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA Analysis Set: all participants who received at lease one dose of study drug and had both baseline ADA and at least one post-dose ADA measurement in Part A.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants Who Achieved HiSCR90 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.14', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.229', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR90.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5116', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.79', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.294', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR90.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants Who Achieved HiSCR100 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0514', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '13.67', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.019', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR100.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3322', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.56', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.764', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR100.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants Who Achieved HiSCR50 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3258', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '8.63', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.780', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR50.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.28', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.775', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nNon-response imputation was used for participants with missing HiSCR50.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.32', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '32.9'}, {'value': '18.29', 'groupId': 'OG001', 'lowerLimit': '8.43', 'upperLimit': '28.1'}, {'value': '14.93', 'groupId': 'OG002', 'lowerLimit': '5.72', 'upperLimit': '24.1'}]}]}], 'analyses': [{'pValue': '0.3329', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.40', 'pValueComment': 'The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.661', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nMissing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.'}, {'pValue': '0.5882', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.06', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.574', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.\n\nMissing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.'}], 'paramType': 'NUMBER', 'timeFrame': 'Part B: Day 1 through to Week 16', 'description': 'A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline.\n\nMissing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.31', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.995', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6569', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-5.23', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.770', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Week 16', 'description': 'The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.\n\nHurley stages:\n\nStage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B, inclusive only of participants with Hurley Stage II at baseline.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.48', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.951', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0327', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '21.27', 'pValueComment': 'The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.959', 'groupDescription': 'The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Part B: all participants randomized in Part B who had a baseline NRS ≥ 4.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With TEAEs of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W (Up to Week 16)', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg Q2W (Up to Week 16)', 'description': 'Participants received izokibep Q2W in a blinded manor for 16 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg QW (Up to Week 16)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.'}, {'id': 'OG003', 'title': 'Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)', 'description': 'Participants received izokibep QW in a blinded manor for weeks 16-31.'}, {'id': 'OG004', 'title': 'Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)', 'description': 'Participants received izokibep Q2W in a blinded manor for weeks 16-30.'}, {'id': 'OG005', 'title': 'Part B: Izokibep 160 mg QW (Week 16 to 31)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.'}, {'id': 'OG006', 'title': 'Part B: Izokibep 160 mg Q2W (Week 16 to 30)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks', 'description': 'Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: all randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W (Up to Week 16)', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW (Up to Week 16)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W (Up to Week 16)', 'description': 'Participants received izokibep Q2W in a blinded manor for 16 weeks.'}, {'id': 'OG003', 'title': 'Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)', 'description': 'Participants received izokibep QW in a blinded manor for weeks 16-31.'}, {'id': 'OG004', 'title': 'Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)', 'description': 'Participants received izokibep Q2W in a blinded manor for weeks 16-30.'}, {'id': 'OG005', 'title': 'Part B: Izokibep 160 mg QW (Week 16 to 31)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.'}, {'id': 'OG006', 'title': 'Part B: Izokibep 160 mg Q2W (Week 16 to 30)', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks', 'description': 'An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: all randomized participants who received at least one dose of study drug in Part B.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants Testing Positive for ADAs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'OG001', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'OG002', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 weeks', 'description': 'Blood samples were collected at different time points throughout the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA Analysis Set: all participants who received at lease one dose of study drug and had both baseline ADA and at least one post-dose ADA measurement in Part B.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A Izokibep 160 mg QW (Open-label)', 'description': 'Participants with moderate to severe Hidradenitis Suppurativa (HS) received open label izokibep 160 mg by subcutaneous (SC) injection once every week (QW) in Part A for up to 31 weeks.'}, {'id': 'FG001', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or every 2 weeks (Q2W) up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W for up to Week 30.'}, {'id': 'FG002', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'FG003', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'Switched to Izokibep 160 mg QW', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Switched to Izokibep 160 mg Q2W', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Decision by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'Participants were recruited at different centers in the United States, Canada, Germany, Hungary, Poland, and Spain, and participated from May 2022 to February 2024.', 'preAssignmentDetails': 'Part A was a single-arm, open-label, proof-of-concept investigation to explore preliminary efficacy and safety of izokibep.\n\nOnce Part A was fully enrolled, subsequent participants were enrolled into Part B.\n\nPart B was a randomized, double-blind, placebo-controlled, parallel-group, dose-finding investigation to evaluate the efficacy, safety, and immunogenicity of izokibep in participants with moderate to severe hidradenitis suppurativa.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.'}, {'id': 'BG001', 'title': 'Part B Placebo QW/Q2W Then Izokibep QW/Q2W', 'description': 'Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.'}, {'id': 'BG002', 'title': 'Part B Izokibep 160 mg QW', 'description': 'Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.'}, {'id': 'BG003', 'title': 'Part B Izokibep 160 mg Q2W', 'description': 'Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '58', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '9.68', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '9.68', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '11.45', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '11.66', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '10.04', 'groupId': 'BG003'}, {'value': '37.6', 'spread': '11.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Abscess Count', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.18', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '2.18', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.10', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '3.57', 'groupId': 'BG002'}, {'value': '1.9', 'spread': '4.86', 'groupId': 'BG003'}, {'value': '1.9', 'spread': '3.67', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Abcesses', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Inflammatory Nodule Count', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '7.20', 'groupId': 'BG000'}, {'value': '8.8', 'spread': '7.20', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '5.10', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '8.45', 'groupId': 'BG002'}, {'value': '7.9', 'spread': '4.21', 'groupId': 'BG003'}, {'value': '8.5', 'spread': '6.22', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Nodules', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Draining Fistula Count', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.35', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '2.35', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '5.18', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '3.97', 'groupId': 'BG002'}, {'value': '2.6', 'spread': '3.38', 'groupId': 'BG003'}, {'value': '3.1', 'spread': '4.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Fistulas', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}, {'title': 'Abcess and Inflammatory Nodule (AN) Count', 'classes': [{'title': 'Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '7.64', 'groupId': 'BG000'}, {'value': '10.5', 'spread': '7.64', 'groupId': 'BG004'}]}]}, {'title': 'Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '5.24', 'groupId': 'BG001'}, {'value': '11.9', 'spread': '9.50', 'groupId': 'BG002'}, {'value': '9.9', 'spread': '6.85', 'groupId': 'BG003'}, {'value': '10.4', 'spread': '7.42', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Total Abcess/Nodules', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in Part A and Part B of the study were analyzed separately'}], 'populationDescription': 'Full Analysis Set (FAS), Part A: all participants who received at lease one dose of study drug in Part A.\n\nFAS, Part B: all participants randomized in Part B.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-13', 'size': 3314057, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-04T09:49', 'hasProtocol': True}, {'date': '2024-04-04', 'size': 1301857, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-10T13:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2022-04-12', 'resultsFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-16', 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12', 'timeFrame': 'Part A: Baseline to Week 12', 'description': 'HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.'}, {'measure': 'Part B: Number of Participants Who Achieved HiSCR75 at Week 16', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.'}], 'secondaryOutcomes': [{'measure': 'Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks', 'description': 'An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.'}, {'measure': 'Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)', 'timeFrame': 'Baseline, Week 16, Week 32, Week 39', 'description': 'Blood samples were collected at different time points throughout the study.'}, {'measure': 'Part B: Number of Participants Who Achieved HiSCR90 at Week 16', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count'}, {'measure': 'Part B: Number of Participants Who Achieved HiSCR100 at Week 16', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.'}, {'measure': 'Part B: Number of Participants Who Achieved HiSCR50 at Week 16', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count'}, {'measure': 'Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment', 'timeFrame': 'Part B: Day 1 through to Week 16', 'description': 'A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline.\n\nMissing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.'}, {'measure': 'Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2', 'timeFrame': 'Part B: Week 16', 'description': 'The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16.\n\nHurley stages:\n\nStage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.'}, {'measure': 'Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4', 'timeFrame': 'Part B: Baseline to Week 16', 'description': 'The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".'}, {'measure': 'Part B: Number of Participants With TEAEs of Special Interest', 'timeFrame': 'Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks', 'description': 'Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.'}, {'measure': 'Part B: Number of Participants With TEAEs', 'timeFrame': 'Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks', 'description': 'An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.'}, {'measure': 'Part B: Number of Participants Testing Positive for ADAs', 'timeFrame': 'Up to 39 weeks', 'description': 'Blood samples were collected at different time points throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hidradenitis suppurativa', 'Izokibep'], 'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS).\n\nThis study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral\n\n* Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* 18 years to 75 years of age\n\nType of Subject and Disease Characteristics\n\n* Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug.\n* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III.\n* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization.\n* Subject must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS.\n* Must agree to use daily over-the-counter topical antiseptics.\n* Subject must be willing to complete a daily skin pain diary for at least 3 days prior to Day 1 visit.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* Draining fistula count of \\> 20.\n* Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization.\n* Other active skin disease or condition that could interfere with study assessments.\n* Chronic pain not associated with HS.\n* Uncontrolled, clinically significant system disease.\n* History of demyelinating disease or neurological symptoms suggestive of demyelinating disease.\n* Malignancy within 5 years.\n* The subject is at risk of self-harm or harm to others.\n* Active infection or history of certain infections.\n* Tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening (Exception: documented evidence of completed treatment and clinically resolved).\n* Known history of human immunodeficiency virus (HIV).\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05355805', 'briefTitle': 'Hidradenitis Suppurativa Phase 2b Study of Izokibep', 'organization': {'class': 'INDUSTRY', 'fullName': 'ACELYRIN Inc.'}, 'officialTitle': 'A Phase 2b Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': '21102'}, 'secondaryIdInfos': [{'id': '2021-005713-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A (Open-label) izokibep every week', 'description': 'Participants will receive izokibep every week from Day 1 through Week 31', 'interventionNames': ['Drug: Izokibep']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Double-blind) izokibep every week', 'description': 'Participants will receive izokibep every week for 31 weeks.', 'interventionNames': ['Drug: Izokibep']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Double-blind) izokibep every other week', 'description': 'Participants will receive izokibep every other week for 30 weeks.', 'interventionNames': ['Drug: Izokibep']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B (Double-blind) placebo every week', 'description': 'Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.', 'interventionNames': ['Drug: Placebo to izokibep']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B (Double-blind) placebo every other week', 'description': 'Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.', 'interventionNames': ['Drug: Placebo to izokibep']}], 'interventions': [{'name': 'Izokibep', 'type': 'DRUG', 'description': 'Biologic: IL-17A inhibitor\n\nForm: Solution for injection\n\nRoute of administration: Subcutaneous (SC)', 'armGroupLabels': ['Part A (Open-label) izokibep every week', 'Part B (Double-blind) izokibep every other week', 'Part B (Double-blind) izokibep every week']}, {'name': 'Placebo to izokibep', 'type': 'DRUG', 'description': 'Form: Solution for injection\n\nRoute of administration: Subcutaneous (SC)', 'armGroupLabels': ['Part B (Double-blind) placebo every other week', 'Part B (Double-blind) placebo every week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-3110', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91436-2428', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92708-3701', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Clinical 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{'zip': '40-615', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '20-573', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '70-332', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'PM', 'country': 'Spain', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '36001', 'city': 'Pontevedra', 'state': 'PO', 'country': 'Spain', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '46940', 'city': 'Manises', 'state': 'V', 'country': 'Spain', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.49139, 'lon': -0.46349}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Donald Betah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ACELYRIN Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ACELYRIN Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}