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A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT05076175•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Age

2 - 17 years

Sex

ALL

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

Locations (90)

Local Institution - 0041

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Local Institution - 0052

Garden Grove, California, United States

Loma Linda University Health System

Loma Linda, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

Local Institution - 0096

Sacramento, California, United States

Local Institution - 0007

Hartford, Connecticut, United States

Local Institution - 0064

Washington D.C., District of Columbia, United States

Local Institution - 0075

Orlando, Florida, United States

Key Dates

Start Date

May 30, 2022

Primary Completion Date

May 22, 2026

Completion Date

August 14, 2031

Last Updated

March 11, 2026

Enrollment

120

ESTIMATED participants

Conditions

Colitis, Ulcerative

Interventions

Ozanimod

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Diet Intervention Treatment for Active Ulcerative Colitis

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