Oral Ozanimod for Crohn's Disease

Verified Trial

Phase 3

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Crohn's disease for ≥ 3 months on endoscopy and on histological exam

Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug to see if it can help people with Crohn's Disease.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Ozanimod may cause side effects like headaches, high blood pressure, liver enzyme elevations, infections due to lowered immunity, and possibly heart rate issues when first taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Crohn's disease for at least 3 months.

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

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

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I do not have ulcerative colitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150

Secondary study objectives

Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score

Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150

Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50%

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