NCT05242484

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
BIOLOGICAL	Guselkumab	Guselkumab will be administered as subcutaneous injection.
BIOLOGICAL	Golimumab	Golimumab will be administered as subcutaneous injection.
BIOLOGICAL	JNJ-78934804	JNJ-78934804 will be administered subcutaneously as per defined regimen.
DRUG	Placebo	Placebo will be administered as subcutaneous injection.

Timeline

• Start date: 2022-09-19
• Primary completion: 2025-05-15
• Completion: 2029-03-27
• First posted: 2022-02-16
• Last updated: 2026-04-13

Locations

403 sites across 37 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study