A Phase 3 Randomized Double-blind Placebo- and Active-controlled Parallel-group Multicenter Protocol to Evaluate the Safety and Efficacy of Guselkumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease

Go Back to All Clinical Trials

A Phase 3 Randomized Double-blind Placebo- and Active-controlled Parallel-group Multicenter Protocol to Evaluate the Safety and Efficacy of Guselkumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease

Brief description of study

Under this protocol, there are 3 separate studies: a 48-week Phase 2 dose-ranging study (ie, GALAXI 1) and 2 identical 48-week Phase 3 confirmatory studies (ie, GALAXI 2 and GALAXI 3). All 3 studies will be conducted using a treat-through study design, ie, participants are randomized to treatment regimens at Week 0 and will remain on that treatment regimen through at least Week 48 of each study, unless otherwise indicated.

Clinical Study Identifier: s17-00614

ClinicalTrials.gov Identifier: NCT03466411

Clinical Research Studies

A Phase 3 Randomized Double-blind Placebo- and Active-controlled Parallel-group Multicenter Protocol to Evaluate the Safety and Efficacy of Guselkumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease

Brief description of study

Recruitment Status

212-263-4432

646-754-7432