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

Have you been diagnosed with Crohn's disease?

Have you previously tried a treatment for Crohn's disease which didn't work?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing if ozanimod can help control Crohn's Disease.

Who is the study for?

This trial is for people with moderately to severely active Crohn's Disease who have tried other treatments that didn't work. It's not for those with ulcerative colitis or conditions that might exclude them from safely participating.

What is being tested?

The study tests ozanimod, an oral medication, as a maintenance therapy against a placebo (a pill without the active drug) to see if it helps keep Crohn's Disease under control.

What are the potential side effects?

Ozanimod may cause side effects like headaches, high blood pressure, liver issues, and could increase the risk of infections due to its immune system effects.

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.

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I have tried a treatment for Crohn's disease that didn't work.

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I do not have ulcerative colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 of < 150

Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50%

Secondary study objectives

Histologic improvement based on differences between ozanimod and placebo in histologic diseaseactivity scores (ie, Global Histologic Disease Activity Score [GHAS] changes)

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

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

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