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

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Trial Profile

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

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

Latest Information Update: 15 Jan 2025

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At a glance

  • Drugs Guselkumab (Primary) ; Guselkumab (Primary) ; Ustekinumab; Ustekinumab
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GALAXI; GALAXI 1; GALAXI 2; GALAXI 3
  • Sponsors Janssen Research & Development; Janssen-Cilag; Johnson & Johnson Innovative Medicine

    • Most Recent Events

    • 20 Jun 2024 According to Johnson & Johnson media release, the company announced that, based on the results from Phase 3 GALAXI and GRAVITI programs the company submitted sBLA to FDA seeking approval of TREMFYA for the treatment of adults with moderately to severely active Crohn's disease. This marks the second submission to the FDA for TREMFYA in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis.
    • 30 May 2024 This trial has been completed in Lithuania and Austria, according to an European Clinical Trials Database record.
    • 30 May 2024 This trial has been completed in Lithuania and Austria, according to an European Clinical Trials Database record.

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