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

NCT05076175 · tracked via the Priya Life Science Spain tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2/3

Started

2022-05-30

Last updated

2026-09-24

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Ozanimod →

Ozanimod: Specified dose on specified days

Study summary

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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

17 Years

Healthy volunteers

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

Primary outcome measure(s)

Proportion of participants who achieve clinical remission — At Week 52

Trial sites (91)

Facility	City	Region	Status
Local Institution - 0041	Phoenix	Arizona	Withdrawn
University of Arizona	Tucson	Arizona	Withdrawn
Local Institution - 0052	Garden Grove	California	Completed
Loma Linda University Health System	Loma Linda	California	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
Lucile Packard Children's Hospital	Palo Alto	California	Not Yet Recruiting
University of California Davis Health	Sacramento	California	Recruiting
Local Institution - 0007	Hartford	Connecticut	Completed
Local Institution - 0064	Washington D.C.	District of Columbia	Completed
Local Institution - 0075	Orlando	Florida	Completed
Local Institution - 0016	Atlanta	Georgia	Completed
Local Institution - 0101	Park Ridge	Illinois	Not Yet Recruiting
Local Institution - 0100	Indianapolis	Indiana	Not Yet Recruiting
Local Institution - 0049	Iowa City	Iowa	Completed
Maine Medical Partners	Portland	Maine	Not Yet Recruiting
Boston Children's Hospital	Boston	Massachusetts	Recruiting
Local Institution - 0042	Springfield	Massachusetts	Completed
University of Massachusetts Chan Medical School	Worcester	Massachusetts	Recruiting
Local Institution - 0093	Detroit	Michigan	Completed
Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota	Recruiting
Washington University	St Louis	Missouri	Recruiting
Local Institution - 0028	New York	New York	Completed
Columbia University Medical Center	New York	New York	Recruiting
Local Institution - 0023	New York	New York	Withdrawn
University of North Carolina Medical Center	Chapel Hill	North Carolina	Withdrawn
Local Institution - 0047	Charlotte	North Carolina	Completed
Cleveland Clinic	Cleveland	Ohio	Recruiting
Local Institution - 0062	Oklahoma City	Oklahoma	Withdrawn
Local Institution - 0045	Hershey	Pennsylvania	Completed
Local Institution - 0099	Charleston	South Carolina	Not Yet Recruiting
Local Institution - 0103	Fort Worth	Texas	Not Yet Recruiting
Texas Children's Hospital	Houston	Texas	Recruiting
Seattle Children's Hospital	Seattle	Washington	Recruiting
Local Institution - 0091	Seattle	Washington	Completed
MultiCare Health System	Tacoma	Washington	Recruiting
Local Institution - 0037	Milwaukee	Wisconsin	Completed
The Children's Hospital at Westmead	Westmead	New South Wales	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Local Institution - 0086	Murdoch	Western Australia	Withdrawn
Local Institution - 0106	Nedlands	Western Australia	Not Yet Recruiting

+ 51 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05076175 on ClinicalTrials.gov ↗ ← All trials in Spain