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A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Ozanimod (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Acronyms TOUCHSTONE
  • Sponsors Celgene Corporation; Celgene International SARL; Receptos

Most Recent Events

  • 17 Oct 2023 Results of a pooled analysis assessing tolerability and safety of long-term ozanimod treatment from following clinical studies: NCT01647516, NCT02435992, NCT02531126 and NCT02576717 presented at the 31st United European Gastroenterology Week
  • 27 Apr 2023 Results assessing tolerability/safety of extended ozanimod 0.92 mg/day treatment in adults with relapsing multiple sclerosis (RMS) or moderately to severely active ulcerative colitis, presented at the 75th Annual Meeting of the American Academy of Neurology 2023.
  • 27 Oct 2021 Results (n=1158; data cut off date: September 30, 2020) of pooled analysis from UC studies phase 2 and phase 3 assessing the safety of extended exposure to ozanimod HCl 1 mg/day from the Ulcerative Colitis and Relapsing Multiple Sclerosis clinical trials presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021

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