CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 1,409 enrolled / 1,409 target
Drug / intervention
Guselkumab Dose 1 +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03466411
NCT03466411Phase 2ActiveUpdate Overdue (14.3/mo)Completion was 32mo ago
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Mar 15, 2018·Updated Jun 8, 2026

In Brief

A Phase 2 clinical trial evaluating Guselkumab Dose 1, Guselkumab Dose 2, and 6 other interventions for Crohn's Disease. Active but no longer recruiting, targeting 1,409 participants across 577 sites in 43 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 2Active
20182019202020212022202320242025202620272028
First PostedMar 15, 2018
Enrollment StartApr 13, 2018
Primary CompletionOct 20, 2023
Study CompletionJan 28, 2028
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.3 years ago

Arms & Interventions

Phase 2 (GALAXI 1): Group 1 (Guselkumab)experimental

Participants will receive guselkumab (Dose 1) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) phase and continue to receive guselkumab.

Drug: Guselkumab Dose 1Drug: Guselkumab Dose 2
Phase 2 (GALAXI 1): Group 2 (Guselkumab)experimental

Participants will receive guselkumab (Dose 3) by intravenous (IV) infusion, followed by guselkumab (Dose 2) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Drug: Guselkumab Dose 2Drug: Guselkumab Dose 3
Phase 2 (GALAXI 1): Group 3 (Guselkumab)experimental

Participants will receive guselkumab (Dose 4) by intravenous (IV) infusion, followed by guselkumab (Dose 5) by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Drug: Guselkumab Dose 4Drug: Guselkumab Dose 5
Phase 2 (GALAXI 1): Group 4 (Ustekinumab)active_comparator

Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE and continue to receive ustekinumab.

Drug: Ustekinumab
Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)experimental

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (Ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

Drug: UstekinumabDrug: Placebo
Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)experimental

Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the LTE phase and continue to receive guselkumab.

Drug: Guselkumab
Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)active_comparator

Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue ustekinumab may enter the LTE phase and continue to receive ustekinumab.

Drug: Ustekinumab
Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)experimental

Participants will receive placebo administered by intravenous (IV) infusion. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. Participants who are eligible and willing to continue placebo/ustekinumab may enter the LTE and continue to receive placebo/ustekinumab.

Drug: UstekinumabDrug: Placebo

Interventions

Guselkumab Dose 1drug

Guselkumab will be administered by IV infusion.

Guselkumab Dose 2drug

Guselkumab will be administered by SC injection.

Guselkumab Dose 3drug

Guselkumab will be administered by IV infusion.

Guselkumab Dose 4drug

Guselkumab will be administered by IV infusion.

Guselkumab Dose 5drug

Guselkumab will be by SC injection.

Guselkumabdrug

Guselkumab will be administered by IV infusion and SC injection.

Ustekinumabdrug

Ustekinumab will be administered by IV infusion and SC injection.

Placebodrug

Placebo will be administered as IV infusion.