An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

• Status: Not yet recruiting
• Trial end date: 2027-04-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the safety, efficacy, quality of life, and biomarker response in participants with moderate to severe ulcerative colitis in clinical practice.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Ozanimod

Criteria

Inclusion Criteria:

• 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 5 through 9, inclusive

• Report of a previous colonoscopy that documents extent of disease

Exclusion Criteria:

• 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