NCT03466411

A Study of 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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,409 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Guselkumab Dose 1	Guselkumab will be administered by IV infusion.
DRUG	Guselkumab Dose 2	Guselkumab will be administered by SC injection.
DRUG	Guselkumab Dose 3	Guselkumab will be administered by IV infusion.
DRUG	Guselkumab Dose 4	Guselkumab will be administered by IV infusion.
DRUG	Guselkumab Dose 5	Guselkumab will be by SC injection.
DRUG	Guselkumab	Guselkumab will be administered by IV infusion and SC injection.
DRUG	Ustekinumab	Ustekinumab will be administered by IV infusion and SC injection.
DRUG	Placebo	Placebo will be administered as IV infusion.

Timeline

• Start date: 2018-04-13
• Primary completion: 2023-10-20
• Completion: 2028-01-28
• First posted: 2018-03-15
• Last updated: 2026-04-13
• Results posted: 2025-05-07

Locations

577 sites across 43 countries: United States, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Colombia, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, North Macedonia, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Slovakia, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study