Recruiting

Phase 2

Phase 3

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

Sponsor:

Bristol-Myers Squibb

Code:

NCT05076175

Conditions

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Ozanimod

Study Details

Brief 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.

Conditions

Colitis, Ulcerative

Study ID

NCT05076175

Start date

May 30, 2022

Status verified date

Jul, 2026

Completion date

Jul 12, 2032

Anticipated

Primary completion date

Jul 12, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ozanimod High Dose

experimental: Ozanimod Low Dose

Interventions

Ozanimod

Specified dose on specified days

Primary outcome measure

Proportion of participants who achieve clinical remission [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Loma Linda University Health System

Recruiting

Loma Linda, California, United States, 92354

Contacts

Kalyan Ray Parashette, Site 0087

505-274-0704

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Shervin Rabizadeh, Site 0074

310-423-7100

University of California Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Trinh Truong, Site 0096

310-597-1251

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Athos Bousvaros, Site 0005

617-699-1021

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Basavaraj Kerur, Site 0095

774-441-8082

Mayo Clinic in Rochester, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Michael Stephens, Site 0070

111111

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Charles Samson, Site 0053

513-518-8949

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

JOSEPH PICORARO, Site 0040

212-305-5903

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44124

Contacts

Jessica Barry, Site 0036

216444231

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Lina Karam, Site 0067

832-822-3612

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Ghassan Wahbeh, Site 0060

111111

MultiCare Health System

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Raghu Varier, Site 0046

503-847-4748

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

Ulcerative Colitis
Ozanimod
Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-07-23.