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

Phase 2

Recruiting

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Ozanimod

• Registration Number: NCT05076175
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-13
• Study Start: 2022-05-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-26
• Primary Completion: 2026-05-22
• Study Completion: 2031-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozanimod High Dose	Ozanimod	-
Ozanimod Low Dose	Ozanimod	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants who achieve clinical remission	At Week 52

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in ALC	Up to 6 years
Proportion of participants who achieve symptomatic remission	At Week 10 and Week 52
Incidence of Serious Adverse Events	Up to 6 years
Incidence of AEs leading to discontinuation from treatment	Up to 6 years
Absolute change from baseline in Absolute Lymphocyte Count (ALC)	Up to 6 years
Proportion of participants who achieve clinical remission	At Week 10
Incidence of AEs of special interest (AESIs)	Up to 6 years
Time to achievement of symptomatic remission	Up to 6 years
Proportion of participants who achieve corticosteroid free remission	At Week 52
Steady state systemic exposure of ozanimod and CC112273	At Week 18 and throughout the study, up to 70 weeks
Proportion of participants who achieve clinical response	At Week 10
Proportion of participants who achieve endoscopic improvement	At Week 10 and Week 52
Incidence of Adverse Events (AEs)	Up to 6 years

Trial Locations

Locations (85)

Local Institution - 0041; 🇺🇸 Phoenix, Arizona, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Local Institution - 0052; 🇺🇸 Garden Grove, California, United States

Local Institution - 0087; 🇺🇸 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

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