Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 9:03 PM
Study NCT ID:
NCT05369832
Status:
TERMINATED
Last Update Posted:
2025-05-20
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Sponsor:
Organization:
Raw JSON
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2'}, {'measure': 'Proportion of participants who achieve endoscopic response', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants who achieve endoscopic improvement', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants who achieve histological improvement', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with IBDQ remission with total score of ≥ 170 points', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants who achieve endoscopic remission', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 2 only'}, {'measure': 'Proportion of participants who achieve histological remission', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 2 only'}, {'measure': 'Corticosteroid-free clinical remission as measured by modified Mayo score', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 2 only'}, {'measure': 'Proportion of participants with histo-endoscopic mucosal improvement', 'timeFrame': 'Up to approximately 26 weeks', 'description': 'Cohort 2 only'}, {'measure': 'Proportion of participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with AEs of interest (AEI)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with AEs leading to discontinuation', 'timeFrame': 'Up to approximately 2 years', 'description': 'Cohort 1 and 2'}, {'measure': 'Proportion of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to approximately 2 years', 'description': 'Cohort 1 and 2'}, {'measure': 'Clinical remission by partial Mayo score', 'timeFrame': 'Up to approximately 104 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Corticosteroid-free clinical remission by partial Mayo', 'timeFrame': 'Up to approximately 104 weeks', 'description': 'Cohort 1 and 2'}, {'measure': 'Clinical response by partial Mayo score', 'timeFrame': 'Up to approximately 104 weeks', 'description': 'Cohort 1 and 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Ozanimod', 'RPC-1063', 'Zeposia®', 'Inflammatory bowel disease'], 'conditions': ['Colitis, Ulcerative']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration\n* Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:\n\n i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).\n* Report of a previous colonoscopy that documents extent of disease\n\nExclusion Criteria:\n\n* Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation\n* Extensive colonic resection or current stoma\n* Colonic dysplasia that has not been removed\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05369832', 'briefTitle': 'An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 4, Prospective, 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