CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 350 enrolled / 350 target
Drug / intervention
Guselkumab Dose 1 +3 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/NCT05197049
NCT05197049Phase 3ActiveUpdate Overdue (6.6/mo)Completion was 35mo ago
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

Janssen Research & Development, LLC·interventional·Posted Jan 19, 2022·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Guselkumab Dose 1, Guselkumab Dose 2, and 2 other interventions for Crohn Disease. Active but no longer recruiting, targeting 350 participants across 345 sites in 27 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesAustralia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Jordan, Lithuania, Malaysia, Netherlands, New Zealand, Poland, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3Active
20222023202420252026202720282029
First PostedJan 19, 2022
Enrollment StartJan 19, 2022
Primary CompletionJul 4, 2023
Study CompletionOct 30, 2028
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.5 years ago

Arms & Interventions

Group 1: Guselkumabexperimental

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Drug: Guselkumab Dose 1Drug: Guselkumab Dose 2
Group 2: Guselkumabexperimental

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Drug: Guselkumab Dose 1Drug: Guselkumab Dose 3
Group 3: Placeboplacebo_comparator

Participants will receive placebo injection subcutaneously.

Drug: Placebo

Interventions

Guselkumab Dose 1drug

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Guselkumab Dose 2drug

Guselkumab (Dose 2) will be administered by SC injection.

Guselkumab Dose 3drug

Guselkumab (Dose 3) will be administered by SC injection.

Placebodrug

Placebo will be administered by SC injection.