for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



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.

Official Title

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).


Fistulizing Crohns Disease, Perianal Crohns Disease, Crohn Disease, Guselkumab


You can join if…

Open to people ages 18 years and up

  • Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
  • Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
  • Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)

You CAN'T join if...

  • Has a very severe luminal disease activity
  • History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease
  • Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
  • Any medical contraindications preventing study participation
  • Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease


  • University of California San Diego Medical Center not yet accepting patients
    La Jolla California 92037 United States
  • Precision Research Institute withdrawn
    San Diego California 92114 United States


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Janssen-Cilag Ltd.
Phase 3 research study
Study Type
Expecting 280 study participants
Last Updated