Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study
Gastroenterology 2023;165:1588 doi 10.1053/j.gastro.2022.01.047
Guselkumab induced greater clinical and endoscopic improvements in patients with Crohn’s disease versus placebo, with a favourable safety profile in this Phase 2 trial by Sandborn, et al.
GALAXI-1 was a Phase 2, double-blind, placebo-controlled study where patients were randomised 1:1:1:1:1 to placebo, guselkumab 200mg, guselkumab 600mg, guselkumab 1200mg, or ustekinumab and observed up to 12 weeks. The primary endpoint was a change from baseline in CDAI score at Week 12.