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

Recruiting now · Phase 2/Phase 3

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT05076175

Run by

Bristol-Myers Squibb

People needed

120

Starts

2022-05-30

Expected to finish

2032-07-12

Last updated by the study team

2026-07-23

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centre Hospitalier Régional de la Citadelle — Liège, Belgium (enrolling)
• Kurume University Hospital — Kurume-shi, Fukuoka, Japan (enrolling)
• MultiCare Health System — Tacoma, Washington, United States (enrolling)
• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)
• Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel (enrolling)
• Aichi Children's Health and Medical Center — Ōbu, Aichi-ken, Japan (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Monash Health — Clayton, Victoria, Australia (enrolling)
• Universitätsklinikum Leipzig — Leipzig, Saxony, Germany (enrolling)
• Schneider Children's Medical Center — Petah Tikva, Central District, Israel (enrolling)
• University of California Davis Health — Sacramento, California, United States (enrolling)
• Rambam Health Care Campus — Haifa, Northern District, Israel (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Loma Linda University Health System — Loma Linda, California, United States (enrolling)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• CHU de Toulouse - Hôpital des Enfants — Toulouse, Haute-Garonne, France (enrolling)
• Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre — Caen, France (enrolling)
• Komatsu Municipal Hospital — Komatsu, Ishikawa-ken, Japan (enrolling)

Full record on ClinicalTrials.gov

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