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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2025

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At a glance

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

Most Recent Events

  • 17 Oct 2023 Results of post hoc analysis from True North trial assessing patterns of OZA response trajectories during the TN maintenance period (MP) in W10 OZA clinical responders who were rerandomized to continue OZA (OZA/OZA arm; n=230) in MP presented at the 31st United European Gastroenterology Week
  • 17 Oct 2023 Results (n=128) of an analysis assessing effect of prior biologic exposure on the durability of OZA efficacy in pts with mod/sev UC from TRUE NORTH trial and its OLE presented at the 31st United European Gastroenterology Week
  • 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

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