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

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Colitis, Ulcerative

Treatments

Drug: Ozanimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT05076175

IM047-001

2021-002308-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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