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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
  2. Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
  3. 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

Exclusion Criteria:

  1. Diagnosis of Crohn's disease or indeterminate colitis
  2. Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
  3. Apheresis within 2 weeks of randomization
  4. 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

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Study Locations

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How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Colitis, Ulcerative
Age (in years)
2 - 17
Phase
Phase 2/Phase 3
Participants needed
120
Est. Completion Date
Aug 14, 2031
Treatment type
Interventional

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT05076175
Study number
IM047001

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