Oral Ozanimod for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+617 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Celgene

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with Crohn's Disease who haven't had success with steroids, immune system modifiers, or biologic therapies. Participants should have been diagnosed at least 3 months ago via endoscopy and tissue exam. Those with ulcerative colitis cannot join.

Inclusion Criteria

My condition didn't improve with steroids, immune treatments, or biologics.

My condition didn't improve with steroids, immune treatments, or biologic therapy.

I do not have ulcerative colitis.

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Exclusion Criteria

Treatment Details

Interventions

Ozanimod (Sphingosine 1-phosphate receptor modulator)
Placebo (Other)

Trial OverviewThe study tests oral ozanimod as a starting treatment for those with moderate to severe Crohn's Disease. It compares the effects of ozanimod against a placebo (a pill without active medication) to see if it helps reduce disease activity.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Administration of oral OzanimodExperimental Treatment1 Intervention

Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation

Group II: Administration of PlaceboPlacebo Group1 Intervention

Subjects will receive placebo capsule orally starting with a 7-day dose escalation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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