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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

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

Latest Information Update: 20 Nov 2025

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At a glance

  • Drugs Guselkumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ASTRO
  • Sponsors Janssen Research & Development

Most Recent Events

  • 24 Oct 2025 According to a Johnson & Johnson media release, the European Commission (EC) has approved a subcutaneous (SC) induction dose regimen of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis, based on results from the Phase 3 ASTRO trial.
  • 07 Oct 2025 Results presented in a Johnson & Johnson media release
  • 07 Oct 2025 According to a Johnson & Johnson media release, the company announced new 48-week data from the Phase 3 ASTRO study in adults with moderately to severely active ulcerative colitis (UC), with trial abstracts being presented at the United European Gastroenterology (UEG) Week 2025.

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