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Ozanimod for Moderate to Severe Ulcerative Colitis in Children

This study is looking into how well and how safely ozanimod (RPC1063) works for children and teenagers (ages 2 to 17) who have moderate to severe ulcerative colitis (UC). UC is a long-lasting disease that causes inflammation in the large intestine. Participants in this study have not responded well to other treatments for their UC. Ozanimod is given by mouth. The main goal is to see how many participants achieve clinical remission (meaning their UC symptoms significantly improve or disappear) after 52 weeks. The current status of this study is unclear, and it plans to enroll about 120 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 120 participants aged 2 to 17 years old.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 52, which suggests participants will be followed for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05076175

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

Recruiting
PHASE2Ages 2–17InterventionalTreatment
Bristol-Myers Squibb
~120 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Ozanimod

At a glance

Recruiting sites
40 of 90 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who achieve clinical remission
Measured over At Week 52

Conditions

Colitis, Ulcerative

Explore related trials

Ulcerative Colitis

Where it's being run

90 sites across 60 states
California5
Belgium4
France4
Massachusetts3
New York3
Washington3
Ontario3
Tokyo3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

Exclusion

Diagnosis of Crohn's disease or indeterminate colitis
Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
Apheresis within 2 weeks of randomization
History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

What this trial measures

  • Proportion of participants who achieve clinical remissionAt Week 52