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: 22 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
- 21 May 2024 Primary endpoint has been met. (Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48 for TREMFYA 200mg SC q4w versus ustekinumab)
- 21 May 2024 Primary endpoint has not been met. (Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48 for TREMFYA 100mg SC q4w versus ustekinumab)
- 21 May 2024 Primary endpoint has not been met. (Phase 3: Clinical Response at Week 12 and Clinical Remission at Week 48 for TREMFYA 100mg SC q4w versus ustekinumab)