Investigating Ozanimod for Children with Moderate to Severe Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of ozanimod (RPC1063), an oral medication, in achieving and maintaining clinical remission in pediatric patients suffering from moderate to severe active ulcerative colitis. Participants must have previously shown inadequate response to conventional therapies. The study aims to provide a new treatment option for children who struggle with this chronic condition.

Why it matters

Who can join: the full rules

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

Where it's running

• Loma Linda University Health System
  Loma Linda, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California Davis Health
  Sacramento, California, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• University of Massachusetts Chan Medical School
  Worcester, Massachusetts, United States Recruiting
• Mayo Clinic in Rochester, Minnesota
  Rochester, Minnesota, United States Recruiting

+41 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.