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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Jun 2025

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At a glance

  • Drugs Ozanimod (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors Bristol-Myers Squibb; Celgene International SARL

Most Recent Events

  • 02 Jun 2022 Planned End Date changed from 14 Jul 2031 to 14 Aug 2031.
  • 02 Jun 2022 Planned primary completion date changed from 21 Apr 2026 to 22 May 2026.
  • 26 May 2022 Planned End Date changed from 13 Jan 2031 to 14 Jul 2031.

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