NCT03662542

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (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 clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Guselkumab Dose 1	Guselkumab Dose 1 will be administered as IV infusion.
DRUG	Guselkumab Dose 2	Guselkumab Dose 2 will be administered as SC injection.
DRUG	Golimumab Dose 1	Golimumab Dose 1 will be administered as SC injection.
DRUG	Golimumab Dose 2	Golimumab Dose 2 will be administered as SC injection.
DRUG	Placebo	Placebo will be administered.

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-12-01
• Completion: 2021-11-15
• First posted: 2018-09-07
• Last updated: 2023-12-12
• Results posted: 2023-12-12

Locations

82 sites across 9 countries: United States, Argentina, Australia, Brazil, Germany, Mexico, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study