What is the Purpose of this Study?
The purpose of this study is to determine whether the experimental combination of guselkumab and golimumab is safe and effective for treating patients with moderately to severely active ulcerative colitis. Treatment with three different doses of the combination will be compared against treatment with guselkumab or golimumab alone. Participants will be randomly assigned to receive guselkumab only, golimumab only, a combination of both guselkumab and golimumab, or placebo. 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 works by blocking both IL-23 and TNF.
Eligibility
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
- Moderately to severely active UC as assessed by the modified Mayo Score
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
- If female and of childbearing potential, must meet the contraception and reproduction requirements
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
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