Status:
RECRUITING
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
PHASE3
Brief Summary
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 participa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 14 2031
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05076175
Start Date
May 30 2022
End Date
August 14 2031
Last Update
March 11 2026
Active Locations (90)
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1
Local Institution - 0041
Phoenix, Arizona, United States, 85016-7710
2
University of Arizona
Tucson, Arizona, United States, 85724
3
Local Institution - 0052
Garden Grove, California, United States, 92845
4
Loma Linda University Health System
Loma Linda, California, United States, 92354