The purpose of this study is to determine whether the investigational combination of 2 drugs, guselkumab and golimumab, is safe and effective for treating patients with moderately to severely active Crohn’s disease. 3 different doses of the combination will be compared against treatment with guselkumab or golimumab alone. Guselkumab works by blocking an inflammatory protein made by the immune cells called interleukin (IL-23). Golimumab works by blocking an inflammatory protein made by immune cells called tumor necrosis factor (TNF). The combination of guselkumab and golimumab (known as JNJ-78934804) works by blocking both IL-23 and TNF. Participants will be randomly assigned to 1 of 6 treatment groups and will receive guselkumab only, golimumab only, a combination of both guselkumab and golimumab, or placebo (inactive substance). Study visits will consist of laboratory tests, physical exams, questionnaires, and endoscopies.
What is the full name of this clinical trial?
A Phase 2b Randomized, Double-blind, Active-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 Crohn's Disease
Crohn's disease [regional enteritis]
Andrea Banty, Gaurav Syal, Susie Lee