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 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

Next Previous
Search
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: 01 Apr 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) ; 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

  • 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
  • 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.

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