A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Fistulizing Crohns Disease, Perianal Crohns Disease
In brief
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.
Key facts
- Study ID
- NCT05347095
- Run by
- Janssen-Cilag Ltd.
- People needed
- 288
- Starts
- 2022-09-27
- Expected to finish
- 2027-03-25
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Semmelweis Egyetem 1 — Budapest, Hungary
- University of Miami — Miami, Florida, United States
- Semmelweis Egyetem 2 — Budapest, Hungary
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Gastroenterology Group Of Naples — Naples, Florida, United States
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando — Orlando, Florida, United States
- Kansas University Medical Center — Kansas City, Kansas, United States
- University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
- University of Louisville — Louisville, Kentucky, United States
- Washington University School Of Medicine — St Louis, Missouri, United States
- Mount Sinai School of Medicine — New York, New York, United States
- Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States
- Gastro One — Germantown, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Tyler Research Institute, LLC — Tyler, Texas, United States
- Swedish Medical Center — Seattle, Washington, United States
- Flinders Medical Centre — Adelaide, Australia
- St Vincent's Hospital - Melbourne — Fitzroy, Australia
- Liverpool Hospital — Liverpool, Australia
- Fiona Stanley Hospital — Murdoch, Australia
- Royal Prince Alfred Hospital — Newtown, Australia
- Royal Adelaide Hospital — North Terrace, Australia
- Royal Melbourne Hospital — Parkville, Australia
- Royal Perth Hospital — Perth, Australia
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.