Ozanimod for Ulcerative Colitis

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with moderate to severe ulcerative colitis, confirmed by a colonoscopy within the last 60 days. Participants should have active symptoms for at least 3 months and meet specific disease activity scores. Those with recent severe complications, major surgery on the colon, or unremoved colonic dysplasia cannot join.

Inclusion Criteria

My ulcerative colitis is moderate to severe, based on a specific score.

I have been diagnosed with ulcerative colitis for at least 3 months.

Exclusion Criteria

I have abnormal colon cells that haven't been removed.

I have had a major surgery to remove part of my colon or I currently have a stoma.

Treatment Details

The study is testing Ozanimod's effects on safety, effectiveness in controlling UC symptoms, impact on quality of life, and changes in biomarkers that indicate disease activity among patients as they receive treatment during regular clinical care.

2Treatment groups

Experimental Treatment

Group I: Cohort 2 - Advanced therapy-exposedExperimental Treatment1 Intervention

Group II: Cohort 1 - Advanced therapy-naiveExperimental Treatment1 Intervention

Ozanimod is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Ozanimod for: