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A 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 Crohn's Disease

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Trial Profile

A 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 Crohn's Disease

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

Latest Information Update: 16 Jul 2026

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At a glance

  • Drugs Guselkumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GRAVITI
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 03 Feb 2026 The trial has been completed in Italy and France.
  • 29 Aug 2025 Planned End Date changed from 27 Mar 2028 to 30 Oct 2028.
  • 07 May 2025 According to a Johnson & Johnson media release, the European Commission (EC) has approved a Marketing Authorization (MA) for TREMFYA (guselkumab), for the treatment of adults with moderately to severely active Crohn's disease (CD) and who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological treatment. This approval is supported by results from the Phase 3 GALAXI and GRAVITI programs.

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