NCT05197049

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (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 efficacy and safety of guselkumab in participants with Crohn's disease.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Guselkumab Dose 1	Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.
DRUG	Guselkumab Dose 2	Guselkumab (Dose 2) will be administered by SC injection.
DRUG	Guselkumab Dose 3	Guselkumab (Dose 3) will be administered by SC injection.
DRUG	Placebo	Placebo will be administered by SC injection.

Timeline

• Start date: 2022-01-19
• Primary completion: 2023-07-04
• Completion: 2028-10-30
• First posted: 2022-01-19
• Last updated: 2026-04-13
• Results posted: 2025-02-21

Locations

345 sites across 27 countries: United States, Australia, 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)

Regulatory

• FDA-regulated drug study