Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top