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
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
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.
Inclusion Criteria:
Exclusion Criteria:
North Terrace, 5000, Australia
Campinas, 13060-904, Brazil
Goiânia, 74535-170, Brazil
Santos São Paulo, 11075-101, Brazil
São José do Rio Preto, 15090-000, Brazil
Guangzhou, 510610, China
Chambray Les Tours Centre, 37170, France
Bear Sheva, 84100, Israel
Cagliari, 09042, Italy
Higashiibaraki-gun, 311-3193, Japan
Sapporo Chuo-ku, 064-0919, Japan
Shinjuku-ku, 169-0073, Japan
Suita-shi, 565-0871, Japan
Tomishiro, 901-0243, Japan
Ain Wazein, Lebanon
Johor Bharu, 80100, Malaysia
Sittard-Geleen, 6130 MB, Netherlands
Torun, 87 100, Poland
Włocławek, 87-800, Poland
Novosibirsk, 630117, Russia
Tunis Jebbari, 1007, Tunisia
Kharkiv, 61037, Ukraine
Kyiv, 03037, Ukraine
Kyiv, 03049, Ukraine
Uzhhorod, 88018, Ukraine