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A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Guselkumab (Primary) ; Guselkumab (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Acronyms QUASAR
  • Sponsors Janssen Pharmaceutical KK; Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 25 Apr 2025 According to a Johnson & Johnson media release, based on data from QUASAR programme, the European Commission (EC) has approved a Marketing Authorisation (MA) for TREMFYA (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
  • 10 Oct 2024 According to a Johnson & Johnson media release, results findings from this trial being presented in 4 Podium Presentations and 1 Moderated Poster at the United European Gastroenterology (UEG) Week 2024.
  • 10 Oct 2024 Results from this trial presented in a Johnson & Johnson media release.

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