What is the Purpose of this Study?
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.
Eligibility
- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
- 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-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