Home › Trials › NCT05076175

Investigating Ozanimod for Children with Moderate to Severe Ulcerative Colitis

A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT05076175

This study is testing a new oral medication called ozanimod to see if it can help children with moderate to severe ulcerative colitis feel better and stay well after other treatments haven't worked.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment120 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations90 sites (Phoenix, Arizona and 89 other locations)
Trial IDNCT05076175 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of ozanimod (RPC1063), an oral medication, in achieving and maintaining clinical remission in pediatric patients suffering from moderate to severe active ulcerative colitis. Participants must have previously shown inadequate response to conventional therapies. The study aims to provide a new treatment option for children who struggle with this chronic condition.

Who should consider this trial

Good fit: Ideal candidates are children diagnosed with moderate to severe active ulcerative colitis who have not responded adequately to standard treatments.

Not a fit: Patients with Crohn's disease or those who have not had an inadequate response to previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for pediatric patients with ulcerative colitis by achieving remission.

How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion 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 treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

Exclusion Criteria

* 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
* Other protocol-defined inclusion/exclusion criteria apply

Where this trial is running

Phoenix, Arizona and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colitis, UlcerativeUlcerative ColitisOzanimodPediatric
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.