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A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

NCT05347095

Active Not RecruitingPhase 3

Sponsor: Janssen-Cilag Ltd.

Conditions: Fistulizing Crohns Disease, Perianal Crohns Disease

Interventions: Guselkumab, Placebo

Countries: United States, Australia, Belgium, Canada, Czechia, Egypt, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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
* Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)

Exclusion Criteria:

* Has a very severe luminal disease activity
* History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
* 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
Locations (154)
  • Birmingham, Alabama, United States
  • New Haven, Connecticut, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Kansas City, Kansas, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Oklahoma City, Oklahoma, United States
  • Germantown, Tennessee, United States
  • Nashville, Tennessee, United States
  • Tyler, Texas, United States
  • Seattle, Washington, United States
  • Adelaide, Australia
  • Fitzroy, Australia
  • Liverpool, Australia
  • Murdoch, Australia
  • Newtown, Australia
  • North Terrace, Australia
  • Parkville, Australia
  • Perth, Australia
  • South Brisbane, Australia
  • Brussels, Belgium
  • Genk, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Edmonton, Alberta, Canada
  • Halifax, Nova Scotia, Canada
  • + 124 more on CT.gov