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

• Status: Not yet recruiting
• Trial end date: 2031-01-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in causing 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Ozanimod

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

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