Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-05 @ 5:11 PM
Study NCT ID:
NCT03398135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['American Samoa', 'Australia', 'Hungary', 'Malaysia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601773', 'term': 'risankizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1242}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score', 'timeFrame': 'Week 52', 'description': 'Clinical remission per Adapted Mayo Score.'}, {'measure': 'Percentage of Participants with Adverse Events (AE)', 'timeFrame': 'Up to Week 300', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement', 'timeFrame': 'Week 52', 'description': 'Endoscopic improvement per endoscopy subscore.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving histologic-endoscopic mucosal improvement.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission', 'timeFrame': 'Week 52', 'description': 'Endoscopic remission per endoscopy subscore.'}, {'measure': 'Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days', 'timeFrame': 'Week 52', 'description': 'Clinical remission per Adapted Mayo Score.'}, {'measure': 'Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0', 'timeFrame': 'Week 52', 'description': 'Clinical remission per Adapted Mayo Score.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving no bowel urgency.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving no abdominal pain.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0', 'timeFrame': 'Week 52', 'description': 'Endoscopic improvement per endoscopy subscore.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score', 'timeFrame': 'Week 52', 'description': 'Clinical response per Adapted Mayo Score.'}, {'measure': 'Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)', 'timeFrame': 'Week 0 to Week 52', 'description': "The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week."}, {'measure': 'Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)', 'timeFrame': 'Baseline (Week 0) to Week 52', 'description': 'The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving no nocturnal bowel movements.'}, {'measure': 'Sub-Study 1: Percentage of Participants Achieving No Tenesmus', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving no tenesmus.'}, {'measure': 'Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week', 'timeFrame': 'Baseline (Week 0) to Week 52', 'description': 'Change in number of fecal incontinence episodes per week.'}, {'measure': 'Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms', 'timeFrame': 'Baseline (Week 0) to Week 52', 'description': 'Change in number of days per week with sleep interrupted due to UC symptoms.'}, {'measure': 'Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization', 'timeFrame': 'Through Week 52', 'description': 'Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABBV-066', 'BI 655066'], 'conditions': ['Ulcerative Colitis (UC)']}, 'referencesModule': {'references': [{'pmid': '40953785', 'type': 'DERIVED', 'citation': 'Panaccione R, Melmed GY, Drobne D, Kaur M, Danese S, Hisamatsu T, Kalabic J, Chen S, Cheng L, Duan WR, Shah S, Louis E. Impact of Extended Risankizumab Treatment in Patients With Ulcerative Colitis Who Did Not Respond to Induction Treatment. Clin Gastroenterol Hepatol. 2025 Sep 13:S1542-3565(25)00797-9. doi: 10.1016/j.cgh.2025.09.007. Online ahead of print.'}, {'pmid': '40168091', 'type': 'DERIVED', 'citation': 'Reinisch W, Loftus EV Jr, Schreiber S, Rubin DT, Louis E, Hecht PM, Barrachina EM, Kalabic J, Vladea R, Sharma D, Duan WR, Zhang Y, Panaccione R. Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis. J Crohns Colitis. 2025 Apr 4;19(4):jjaf025. doi: 10.1093/ecco-jcc/jjaf025.'}, {'pmid': '39804294', 'type': 'DERIVED', 'citation': "Panaccione R, Louis E, Colombel JF, D'Haens G, Peyrin-Biroulet L, Dubinsky M, Takeuchi K, Rubin DT, Kalabic J, Chien KB, Chen S, Cheng L, Zhang Y, Duan WR, Vladea R, Hecht PM, Morisset P, Schreiber S, Ferrante M. Risankizumab efficacy and safety based on prior inadequate response or intolerance to advanced therapy: post hoc analysis of the INSPIRE and COMMAND phase 3 studies. J Crohns Colitis. 2025 Jan 11;19(1):jjaf005. doi: 10.1093/ecco-jcc/jjaf005."}, {'pmid': '39037800', 'type': 'DERIVED', 'citation': "Louis E, Schreiber S, Panaccione R, Bossuyt P, Biedermann L, Colombel JF, Parkes G, Peyrin-Biroulet L, D'Haens G, Hisamatsu T, Siegmund B, Wu K, Boland BS, Melmed GY, Armuzzi A, Levine P, Kalabic J, Chen S, Cheng L, Shu L, Duan WR, Pivorunas V, Sanchez Gonzalez Y, D'Cunha R, Neimark E, Wallace K, Atreya R, Ferrante M, Loftus EV Jr; INSPIRE and COMMAND Study Group. Risankizumab for Ulcerative Colitis: Two Randomized Clinical Trials. JAMA. 2024 Sep 17;332(11):881-897. doi: 10.1001/jama.2024.12414."}], 'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M16-066', 'label': 'Related Info.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.\n\nExclusion Criteria:\n\n* Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.\n* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.\n* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067."}, 'identificationModule': {'nctId': 'NCT03398135', 'acronym': 'COMMAND', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'M16-066'}, 'secondaryIdInfos': [{'id': '2023-506994-36-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Substudy 1: Double-blind Placebo', 'description': 'Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: placebo for risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 1: Double-blind Risankizumab Dose 1', 'description': 'Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 1: Double-blind Risankizumab Dose 2', 'description': 'Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 2: Open-label (OL) Clinical Assessment Risankizumab', 'description': 'Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 2: OL Therapeutic Drug Monitoring Risankizumab', 'description': 'Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 3: OL Extension Risankizumab', 'description': 'Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'OL Continuous Treatment Extension - Dose 1', 'description': 'Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: risankizumab']}, {'type': 'EXPERIMENTAL', 'label': 'OL Continuous Treatment Extension - Dose 2', 'description': 'Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.', 'interventionNames': ['Drug: risankizumab']}], 'interventions': [{'name': 'risankizumab', 'type': 'DRUG', 'otherNames': ['ABBV-066', 'BI 655066', 'SKYRIZI'], 'description': 'subcutaneous (SC) injection', 'armGroupLabels': ['OL Continuous Treatment Extension - Dose 1', 'OL Continuous Treatment Extension - Dose 2', 'Substudy 1: Double-blind Risankizumab Dose 1', 'Substudy 1: Double-blind Risankizumab Dose 2', 'Substudy 2: OL Therapeutic Drug Monitoring Risankizumab', 'Substudy 2: Open-label (OL) Clinical Assessment Risankizumab', 'Substudy 3: OL Extension Risankizumab']}, {'name': 'placebo for risankizumab', 'type': 'DRUG', 'description': 'subcutaneous (SC) injection', 'armGroupLabels': ['Substudy 1: Double-blind Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92118-1408', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Res. 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