Status:
TERMINATED
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- 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
- Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:
- 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).
- Report of a previous colonoscopy that documents extent of disease
Exclusion
- Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
- Extensive colonic resection or current stoma
- Colonic dysplasia that has not been removed
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
December 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2025
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT05369832
Start Date
December 16 2022
End Date
April 11 2025
Last Update
May 20 2025
Active Locations (85)
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1
Local Institution - 0048
Dothan, Alabama, United States, 36305-1156
2
Local Institution - 0206
Chandler, Arizona, United States, 85224-1636
3
Local Institution - 0216
Gilbert, Arizona, United States, 85297-0425
4
Local Institution - 0125
Sun City, Arizona, United States, 85351-2867