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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorBristol-Myers Squibb

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ozanimod

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators