A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT05076175
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb (Responsible Party)
Last Update Posted: 2023-09-05
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 participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
OFFICIAL TITLE
A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy
INTERVENTION / TREATMENT
Drug: Ozanimod
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-05-30 |
| Primary Completion (Estimated) | 2026-05-22 |
| Study Completion (Estimated) | 2031-08-14 |
| Enrollment (Estimated) | 120 |
| Study Type | Interventional |
| Phase | Phase 2 Phase 3 |
| Other Study ID Numbers |
IM047-001
2021-002308-11 (EudraCT Number)
|