The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).