IM047023 A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants with Moderately to Severely Active Crohn’s Disease with an

NCT05470985

A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants with Moderately to Severely Active Crohn’s Disease with an Inadequate Response to Conventional Therapy

Principal Investigator

Sponsor

Bristol-Myers Squibb Company

The purpose of this study is to see whether ozanimod (RPC1063, also referred to as the ‘study drug’ or ‘study treatment’) is safe and effective for the possible treatment of Crohn’s Disease (CD) in a pediatric population. To do this, participants will be enrolled and treated with ozanimod in order by age group: 12-17 (adolescents), 6-11, and 2-5 years old. Data from the older group(s), will be reviewed before the start of a younger group of participants. While in the study, participants will be treated with one of two doses with an equal chance to receive either dose. You will be evaluated for symptoms, and with endoscopies, laboratory tests and other procedures to monitor your safety.