Ozanimod for Ulcerative Colitis

Recruiting at 178 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Bristol-Myers Squibb

Disqualifiers: Fulminant colitis, Toxic megacolon, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

500 Participants Needed

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

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.

Report of a previous colonoscopy that documents extent of disease

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 severe colon issues or a bowel tear in the last 3 months.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ozanimod to explore safety, efficacy, and biomarker response

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Long-term follow-up

Participants are monitored for long-term safety and adverse events

Up to 2 years

Treatment Details

Interventions

• Ozanimod

Trial Overview 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.

Participant Groups

Group I: Cohort 2 - Advanced therapy-exposed Experimental Treatment 1 Intervention

Group II: Cohort 1 - Advanced therapy-naive Experimental Treatment 1 Intervention

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

Approved in European Union as Ozanimod for:

• Moderate to severe active ulcerative colitis

Approved in United States as Ozanimod for:

• Moderate to severe active ulcerative colitis

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania