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Oral Ozanimod for Ulcerative Colitis in Children

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Recruiting Phase 2 Phase 3 Interventional Study
Colitis, Ulcerative
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for

This trial is looking for children with moderate to severe ulcerative colitis that hasn't responded well to other treatments. Participants will take ozanimod, an oral medication, to see if it helps improve their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with moderate to severe ulcerative colitis.
  • My ulcerative colitis symptoms extend beyond the rectum.
  • I have not responded well to or cannot tolerate at least one UC treatment.

You may not be able to join if

  • I have been diagnosed with Crohn's disease.
  • I have tested positive for Clostridium difficile.
  • I have had apheresis in the last 2 weeks.
  • I have a history of or currently active immune deficiency.
  • I have a genetic disorder that causes my colitis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.

Trial Locations

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Eligibility Criteria
Inclusion Criteria * Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit * Evidence of UC extending beyond the rectum, as determined by baseline endoscopy * Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following …
Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

CONTACT

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CONTACT

NCT ID: NCT05076175 Source: ClinicalTrials.gov