Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05076175

RecruitingPhase 2, Phase 3

Sponsor: Bristol-Myers Squibb

Conditions: Colitis, Ulcerative

Interventions: Ozanimod

Countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Japan

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (90)
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Garden Grove, California, United States
  • Loma Linda, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Sacramento, California, United States
  • Hartford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Park Ridge, Illinois, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Portland, Maine, United States
  • Boston, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Hershey, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • + 60 more on CT.gov