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
Latest Information Update: 06 May 2024
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
- 01 May 2024 According to Johnson & Johnson media release, results of 48 weeks study will be presented at an upcoming medical meeting.
- 01 May 2024 According to Johnson & Johnson media release, along with the data from this study and the Phase 3 QUASAR program, the company has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA (guselkumab) of patients with ulcerative colitis and Crohn's disease.
- 17 Oct 2023 Results (n=151) assessing clinical, endoscopic, and safety outcomes through 3 years in patients receiving maintenance therapy with GUS in GALAXI-1 long-term extension study presented at the 31st United European Gastroenterology Week