Ozanimod for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+1329 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Celgene

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing ozanimod, a medication that helps reduce inflammation, in people with severe Crohn's Disease who may not respond to usual treatments. Ozanimod has been approved for the treatment of ulcerative colitis and is being tested for its effectiveness in Crohn's disease.

Eligibility Criteria

This trial is for people with moderate to severe Crohn's Disease who have finished a previous ozanimod study but are not in remission or response after 12 weeks, or those who relapsed post-study. Participants should not have untreated abscesses and must not be on certain drugs like CYP2C8 inducers or MAO inhibitors.

Inclusion Criteria

My condition did not improve after 12 weeks in the initial treatment study.

Exclusion Criteria

I might have an untreated abscess in my abdomen or near my anus.

I am currently taking drugs that affect enzyme activity or treat depression.

Participant Groups

The trial is testing the long-term safety and effectiveness of a drug called Ozanimod for individuals with Crohn's Disease. It extends prior research by continuing treatment with this medication to see how well it works over a longer period.

1Treatment groups

Experimental Treatment

Group I: Administration of oral OzanimodExperimental Treatment1 Intervention

Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks

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

🇪🇺 Approved in European Union as Ozanimod for: