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

ClinicalTrials.gov ID: NCT05076175

Public ClinicalTrials.gov record NCT05076175. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 9, 2026, 2:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT05076175
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Colitis, Ulcerative

Interventions

Ozanimod Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 29, 2022
Primary completion: Jul 11, 2032
Completion: Jul 11, 2032
Last update posted: Jul 22, 2026

2022 – 2032

United States locations

U.S. sites: 36
U.S. states: 23
U.S. cities: 33

Facility	City	State	ZIP	Site status
Local Institution - 0041	Phoenix	Arizona	85016-7710	Withdrawn
University of Arizona	Tucson	Arizona	85724	Withdrawn
Local Institution - 0052	Garden Grove	California	92845	Completed
Loma Linda University Health System	Loma Linda	California	92354	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
Lucile Packard Children's Hospital	Palo Alto	California	94304	Not yet recruiting
University of California Davis Health	Sacramento	California	95817	Recruiting
Local Institution - 0007	Hartford	Connecticut	06106	Completed
Local Institution - 0064	Washington D.C.	District of Columbia	20010	Completed
Local Institution - 0075	Orlando	Florida	32803	Completed
Local Institution - 0016	Atlanta	Georgia	30342	Completed
Local Institution - 0101	Park Ridge	Illinois	60068	Not yet recruiting
Local Institution - 0100	Indianapolis	Indiana	46202	Not yet recruiting
Local Institution - 0049	Iowa City	Iowa	52242	Completed
Maine Medical Partners	Portland	Maine	04102	Not yet recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting
Local Institution - 0042	Springfield	Massachusetts	01199	Completed
University of Massachusetts Chan Medical School	Worcester	Massachusetts	01655	Recruiting
Local Institution - 0093	Detroit	Michigan	48201	Completed
Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota	55905	Recruiting
Washington University	St Louis	Missouri	63110	Recruiting
Local Institution - 0028	New York	New York	10029	Completed
Columbia University Medical Center	New York	New York	10032	Recruiting
Local Institution - 0023	New York	New York	10065	Withdrawn
University of North Carolina Medical Center	Chapel Hill	North Carolina	27599	Withdrawn
Local Institution - 0047	Charlotte	North Carolina	28203	Completed
Cleveland Clinic	Cleveland	Ohio	44124	Recruiting
Local Institution - 0062	Oklahoma City	Oklahoma	73112	Withdrawn
Local Institution - 0045	Hershey	Pennsylvania	17033	Completed
Local Institution - 0099	Charleston	South Carolina	29425	Not yet recruiting
Local Institution - 0103	Fort Worth	Texas	76104	Not yet recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting
Local Institution - 0091	Seattle	Washington	98122	Completed
MultiCare Health System	Tacoma	Washington	98405	Recruiting
Local Institution - 0037	Milwaukee	Wisconsin	53226	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05076175, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 22, 2026 · Synced Sep 9, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05076175 live on ClinicalTrials.gov.

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