Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03926169
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601773', 'term': 'risankizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 19, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 21, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 26, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 26, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Risankizumab 180 mg / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 12, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Risankizumab 360 mg / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 19, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HIDRADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SUBCUTANEOUS ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'AFFECTIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INTENTIONAL SELF-INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ENDOMETRIOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'OVARIAN CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HIDRADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '29.3', 'upperLimit': '53.7'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '34.2', 'upperLimit': '59.4'}, {'value': '43.4', 'groupId': 'OG002', 'lowerLimit': '31.0', 'upperLimit': '55.8'}]}]}], 'analyses': [{'pValue': '0.422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '6.0', 'ciLowerLimit': '-10.8', 'ciUpperLimit': '22.8', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.858', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.3', 'ciLowerLimit': '-15.4', 'ciUpperLimit': '18.1', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0), Week 16', 'description': 'HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Non-responder imputation with multiple imputation to handle missing data due to COVID-19 (NRI-C) .'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '46.5'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '15.9', 'upperLimit': '42.6'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '25.8', 'upperLimit': '54.2'}]}]}], 'analyses': [{'pValue': '0.725', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-3.0', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '15.9', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.301', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '8.8', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '27.8', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to Week 8', 'description': 'NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '40.7'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '44.7'}, {'value': '38.6', 'groupId': 'OG002', 'lowerLimit': '24.4', 'upperLimit': '52.7'}]}]}], 'analyses': [{'pValue': '0.650', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '3.7', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '21.8', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.147', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '12.3', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '31.3', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '40.5'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '33.0'}, {'value': '18.5', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '28.2'}]}]}], 'analyses': [{'pValue': '0.342', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-6.5', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '8.8', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-10.6', 'ciLowerLimit': '-25.3', 'ciUpperLimit': '4.2', 'pValueComment': 'Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to Week 16', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '-0.4'}, {'value': '-3.5', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-1.8'}, {'value': '-3.7', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '-2.0'}]}]}], 'analyses': [{'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.3', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '0.9', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.97', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.6', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '0.6', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.870', 'groupId': 'OG000', 'lowerLimit': '-1.416', 'upperLimit': '-0.324'}, {'value': '-0.751', 'groupId': 'OG001', 'lowerLimit': '-1.338', 'upperLimit': '-0.165'}, {'value': '-0.885', 'groupId': 'OG002', 'lowerLimit': '-1.436', 'upperLimit': '-0.334'}]}]}], 'analyses': [{'pValue': '0.727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.118', 'ciLowerLimit': '-0.646', 'ciUpperLimit': '0.883', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3385', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.963', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.015', 'ciLowerLimit': '-0.755', 'ciUpperLimit': '0.724', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3273', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.677', 'groupId': 'OG000', 'lowerLimit': '-1.160', 'upperLimit': '-0.195'}, {'value': '-0.635', 'groupId': 'OG001', 'lowerLimit': '-1.149', 'upperLimit': '-0.120'}, {'value': '-0.442', 'groupId': 'OG002', 'lowerLimit': '-0.928', 'upperLimit': '0.044'}]}]}], 'analyses': [{'pValue': '0.886', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.042', 'ciLowerLimit': '-0.622', 'ciUpperLimit': '0.706', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2941', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.409', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.236', 'ciLowerLimit': '-0.408', 'ciUpperLimit': '0.879', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2851', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG001', 'title': 'Risankizumab 180 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}, {'id': 'OG002', 'title': 'Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.630', 'groupId': 'OG000', 'lowerLimit': '-1.154', 'upperLimit': '-0.107'}, {'value': '-0.882', 'groupId': 'OG001', 'lowerLimit': '-1.440', 'upperLimit': '-0.324'}, {'value': '-0.705', 'groupId': 'OG002', 'lowerLimit': '-1.233', 'upperLimit': '-0.176'}]}]}], 'analyses': [{'pValue': '0.434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.252', 'ciLowerLimit': '-0.977', 'ciUpperLimit': '0.473', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3212', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.813', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.074', 'ciLowerLimit': '-0.779', 'ciUpperLimit': '0.631', 'pValueComment': 'Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.3123', 'statisticalMethod': 'mixed-effect model repeat measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.'}, {'id': 'FG001', 'title': 'Risankizumab 180 mg / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.'}, {'id': 'FG002', 'title': 'Risankizumab 360 mg / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.'}], 'periods': [{'title': 'Period A', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'Never Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COVID-19 Infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COVID-19 Logistical Restrictions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period B', 'milestones': [{'type': 'STARTED', 'comment': 'Entered Period B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'Entered Period B and Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'comment': 'Completed study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '71'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other, Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '65'}]}]}], 'preAssignmentDetails': "In Period A, participants who met the study's eligibility criteria were randomized at the Baseline Visit, in a 1:1:1 ratio, to receive either placebo, risankizumab 180 mg or 360 mg via a subcutaneous (SC) injection."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.'}, {'id': 'BG001', 'title': 'Risankizumab 180 mg / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.'}, {'id': 'BG002', 'title': 'Risankizumab 360 mg / Risankizumab 360 mg', 'description': 'In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '11.97', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '11.45', 'groupId': 'BG001'}, {'value': '38.2', 'spread': '11.99', 'groupId': 'BG002'}, {'value': '38.1', 'spread': '11.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Multiple Races', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Abscess and Inflammatory Nodule (AN) Count', 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '28.42', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '11.42', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '8.24', 'groupId': 'BG002'}, {'value': '14.0', 'spread': '18.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'abscess and inflammatory nodules', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-15', 'size': 2428006, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-14T16:28', 'hasProtocol': True}, {'date': '2021-01-19', 'size': 554198, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-14T16:29', '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': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'dispFirstSubmitDate': '2022-01-03', 'completionDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2019-04-23', 'dispFirstSubmitQcDate': '2022-01-03', 'resultsFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2019-04-23', 'dispFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-14', 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16', 'timeFrame': 'Baseline (Week 0), Week 16', 'description': 'HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.'}], 'secondaryOutcomes': [{'measure': "Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3", 'timeFrame': 'Baseline (Week 0) to Week 8', 'description': 'NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.'}, {'measure': 'Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.'}, {'measure': 'Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline', 'timeFrame': 'Baseline (Week 0) to Week 16'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL."}, {'measure': 'Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.'}, {'measure': 'Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.'}, {'measure': 'Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16', 'timeFrame': 'Baseline (Week 0) to Week 16', 'description': 'HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hidradenitis Suppurativa', 'Risankizumab', 'Placebo'], 'conditions': ['Hidradenitis Suppurativa']}, 'referencesModule': {'references': [{'pmid': '36892753', 'type': 'DERIVED', 'citation': 'Kimball AB, Prens EP, Passeron T, Maverakis E, Turchin I, Beeck S, Drogaris L, Geng Z, Zhan T, Messina I, Bechara FG. Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2023 May;13(5):1099-1111. doi: 10.1007/s13555-023-00913-3. Epub 2023 Mar 9.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com', 'label': 'This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant with moderate to severe HS for at least 1 year prior to baseline visit.\n* HS lesions present in at least two distinct anatomical areas.\n* Draining fistula count of ≤ 20 at Baseline visit.\n* Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.\n* Participants are required to use a daily antiseptic wash on their HS lesions.\n* Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.\n\nExclusion Criteria:\n\n* Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.\n* Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.\n* Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.\n* Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.\n* Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.\n* Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.'}, 'identificationModule': {'nctId': 'NCT03926169', 'acronym': 'DETERMINED 1', 'briefTitle': 'A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': 'M16-833'}, 'secondaryIdInfos': [{'id': '2019-000122-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risankizumab 180 mg', 'description': 'In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.', 'interventionNames': ['Drug: Risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab 360 mg', 'description': 'In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.', 'interventionNames': ['Drug: Risankizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.', 'interventionNames': ['Drug: Placebo for risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab 180 mg / Risankizumab 360 mg', 'description': 'In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.', 'interventionNames': ['Drug: Risankizumab', 'Drug: Placebo for risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Risankizumab 360 mg / Risankizumab 360 mg', 'description': 'In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.', 'interventionNames': ['Drug: Risankizumab', 'Drug: Placebo for risankizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo / Risankizumab 360 mg', 'description': 'In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.\n\nIn Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.', 'interventionNames': ['Drug: Risankizumab', 'Drug: Placebo for risankizumab']}], 'interventions': [{'name': 'Risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'SKYRIZI'], 'description': 'Risankizumab is administered as a SC injection in pre-filled syringe (PFS)', 'armGroupLabels': ['Placebo / Risankizumab 360 mg', 'Risankizumab 180 mg', 'Risankizumab 180 mg / Risankizumab 360 mg', 'Risankizumab 360 mg', 'Risankizumab 360 mg / Risankizumab 360 mg']}, {'name': 'Placebo for risankizumab', 'type': 'DRUG', 'description': 'Placebo for risankizumab is administered as a SC injection in PFS', 'armGroupLabels': ['Placebo', 'Placebo / Risankizumab 360 mg', 'Risankizumab 180 mg / Risankizumab 360 mg', 'Risankizumab 360 mg / Risankizumab 360 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913-6404', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research /ID# 211671', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Bakersfield Derma & Skin Cance /ID# 211684', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90056', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Wallace Medical Group /ID# 215958', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95815-4500', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research /ID# 212550', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95816-3300', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Health /ID# 211436', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '91320-2130', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'California Dermatology Institute /ID# 211786', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '06416-1745', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CCD Research, PLLC /ID# 214479', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '30328-6141', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Advanced Medical Research /ID# 215203', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '60008', 'city': 'Rolling Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Arlington Dermatology /ID# 219096', 'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '02111-1552', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center /ID# 212680', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215-5400', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center /ID# 211794', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48059', 'city': 'Fort Gratiot', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hamzavi Dermatology /ID# 212318'}, {'zip': '55455-0356', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota /ID# 212319', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55112', 'city': 'New Brighton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center /ID# 211979', 'geoPoint': {'lat': 45.06552, 'lon': -93.20189}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Skin Specialists, PC /ID# 211675', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}