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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

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: 14 May 2025

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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

  • 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.
  • 28 Mar 2025 According to Johnson & Johnson media release, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for TREMFYA (guselkumab) to include the treatment of adult patients with moderately to severely active Crohns disease based on a review of data from the Phase 3 GALAXI and GRAVITI programmes.
  • 20 Mar 2025 According to Johnson & Johnson media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease (CD), a chronic inflammatory condition of the gastrointestinal tract, this approval is supported by results from Phase 3 GALAXI and GRAVITI programs

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