NCT05076175From ClinicalTrials.govRecruiting

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

Colitis, Ulcerative

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Bristol-Myers Squibb
Enrolment target: 120
Started: 30 May 2022
Main results due: 12 July 2032
Study sites: 91
Registry updated: 24 September 2026

Can you take part?

Ages 2 years to 17 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(91)

Local Institution - 0041
Phoenix, Arizona, United States
Withdrawn
University of Arizona
Tucson, Arizona, United States
Withdrawn
Local Institution - 0052
Garden Grove, California, United States
Completed
Loma Linda University Health System
Loma Linda, California, United States
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Lucile Packard Children's Hospital
Palo Alto, California, United States
Not yet recruiting
University of California Davis Health
Sacramento, California, United States
Recruiting
Local Institution - 0007
Hartford, Connecticut, United States
Completed
Local Institution - 0064
Washington D.C., District of Columbia, United States
Completed
Local Institution - 0075
Orlando, Florida, United States
Completed
Local Institution - 0016
Atlanta, Georgia, United States
Completed
Local Institution - 0101
Park Ridge, Illinois, United States
Not yet recruiting
Local Institution - 0100
Indianapolis, Indiana, United States
Not yet recruiting
Local Institution - 0049
Iowa City, Iowa, United States
Completed
Maine Medical Partners
Portland, Maine, United States
Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, United States
Recruiting
Local Institution - 0042
Springfield, Massachusetts, United States
Completed
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Recruiting
Local Institution - 0093
Detroit, Michigan, United States
Completed
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Recruiting
Washington University
St Louis, Missouri, United States
Recruiting
Local Institution - 0028
New York, New York, United States
Completed
Columbia University Medical Center
New York, New York, United States
Recruiting
Local Institution - 0023
New York, New York, United States
Withdrawn
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Withdrawn
Local Institution - 0047
Charlotte, North Carolina, United States
Completed
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
Local Institution - 0062
Oklahoma City, Oklahoma, United States
Withdrawn
Local Institution - 0045
Hershey, Pennsylvania, United States
Completed
Local Institution - 0099
Charleston, South Carolina, United States
Not yet recruiting
Local Institution - 0103
Fort Worth, Texas, United States
Not yet recruiting
Texas Children's Hospital
Houston, Texas, United States
Recruiting
Seattle Children's Hospital
Seattle, Washington, United States
Recruiting
Local Institution - 0091
Seattle, Washington, United States
Completed
MultiCare Health System
Tacoma, Washington, United States
Recruiting
Local Institution - 0037
Milwaukee, Wisconsin, United States
Completed
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Recruiting
Monash Health
Clayton, Victoria, Australia
Recruiting
Local Institution - 0086
Murdoch, Western Australia, Australia
Withdrawn
Local Institution - 0106
Nedlands, Western Australia, Australia
Not yet recruiting
Local Institution - 0076
Brussels, Bruxelles-Capitale, Région de, Belgium
Withdrawn
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Recruiting
Local Institution - 0056
Brussels, Belgium
Completed
Local Institution - 0063
Edegem, Belgium
Not yet recruiting
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Recruiting
Local Institution - 0071
Liège, Belgium
Withdrawn
Local Institution - 0083
Hamilton, Ontario, Canada
Withdrawn
Local Institution - 0104
Toronto, Ontario, Canada
Withdrawn
Local Institution - 0082
Toronto, Ontario, Canada
Not yet recruiting
CHU de Toulouse - Hôpital des Enfants
Toulouse, Haute-Garonne, France
Recruiting
Local Institution - 0022
Bron, France
Completed
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, France
Recruiting
Local Institution - 0017
Paris, France
Completed
Local Institution - 0073
Paris, France
Withdrawn
Local Institution - 0032
München, Bavaria, Germany
Completed
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Recruiting
Local Institution - 0031
Dresden, Germany
Completed
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Recruiting
Rambam Health Care Campus
Haifa, Northern District, Israel
Recruiting

Showing 60 of 91 sites — filter to narrow it down. 40 of the 91 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05076175. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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