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RecruitingPhase 2/Phase 3

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

Bristol-Myers Squibb · NCT05076175

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
120
US sites recruiting
12
Study start
May 30, 2022
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ozanimod

Conditions: Colitis, Ulcerative

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Loma Linda University Health System

    Loma Linda, CA 92354

    Site contact: Kalyan Ray Parashette, Site 0087 · 505-274-0704

  • Cedars-Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: Shervin Rabizadeh, Site 0074 · 310-423-7100

  • University of California Davis Health

    Sacramento, CA 95817

    Site contact: Trinh Truong, Site 0096 · 310-597-1251

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Athos Bousvaros, Site 0005 · 617-699-1021

  • University of Massachusetts Chan Medical School

    Worcester, MA 01655

    Site contact: Basavaraj Kerur, Site 0095 · 774-441-8082

  • Mayo Clinic in Rochester, Minnesota

    Rochester, MN 55905

    Site contact: Michael Stephens, Site 0070 · 111111

  • Washington University

    St Louis, MO 63110

    Site contact: Charles Samson, Site 0053 · 513-518-8949

  • Columbia University Medical Center

    New York, NY 10032

    Site contact: JOSEPH PICORARO, Site 0040 · 212-305-5903

  • Cleveland Clinic

    Cleveland, OH 44124

    Site contact: Jessica Barry, Site 0036 · 216444231

  • Texas Children's Hospital

    Houston, TX 77030

    Site contact: Lina Karam, Site 0067 · 832-822-3612

  • Seattle Children's Hospital

    Seattle, WA 98105

    Site contact: Ghassan Wahbeh, Site 0060 · 111111

  • MultiCare Health System

    Tacoma, WA 98405

    Site contact: Raghu Varier, Site 0046 · 503-847-4748

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric… (NCT05076175) | Bored Studies