CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 120 target
Drug / intervention
Ozanimoddrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Moderately to severely active ulcerative colitis diagnosed prior to screening
  • ✓Evidence of UC extending beyond the rectum by baseline endoscopy
  • ✓Inadequate response, loss of response to, or intolerant to at least 1 prior UC treatment (aminosalicylates, corticosteroids, immunomodulators, or biologic)
Key exclusion· 4
  • ✕Crohn's disease or indeterminate colitis diagnosis
  • ✕Positive test for toxin-producing Clostridium difficile or PCR stool examination
  • ✕Apheresis within 2 weeks of randomization
  • ✕History of or currently active primary or secondary immunodeficiency, or genetic disorders causing colitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05076175
NCT05076175Phase 2RecruitingOn Track
Long Recruiting
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Oct 13, 2021·Updated Jun 11, 2026

In Brief

A Phase 2 clinical trial evaluating Ozanimod for Colitis, Ulcerative. Currently recruiting, targeting 120 participants across 90 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesAustralia, Belgium, Canada, France, Germany, Israel, Japan, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
20222023202420252026202720282029203020312032
First PostedOct 13, 2021
Enrollment StartMay 30, 2022
Primary CompletionJul 12, 2032
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 4.7 years agoPrimary completion in 6.0 years

Arms & Interventions

Ozanimod High Doseexperimental

Drug: Ozanimod
Ozanimod Low Doseexperimental

Drug: Ozanimod

Interventions

Ozanimoddrug

Specified dose on specified days