Evaluating guselkumab for treating fistulizing perianal Crohn's disease
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
This study is testing if a new medication called guselkumab can help people with Crohn's disease who have painful perianal fistulas feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen-Cilag Ltd. Industry-sponsored |
| Drugs / interventions | infliximab, adalimumab, certolizumab, vedolizumab, upadacitinib, guselkumab |
| Locations | 153 sites (Birmingham, Alabama and 152 other locations) |
| Trial ID | NCT05347095 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness and safety of guselkumab in patients suffering from fistulizing, perianal Crohn's disease. Participants must have a confirmed diagnosis of Crohn's disease with at least one active draining perianal fistula. The study will compare the effects of guselkumab against a placebo to determine its clinical efficacy. Eligible patients include those who have not responded to or are intolerant to certain advanced drug therapies for Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Crohn's disease for at least three months and have at least one active draining perianal fistula.
Not a fit: Patients with very severe luminal disease activity or those with specific concurrent fistula types may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of fistulizing perianal Crohn's disease, offering relief to patients with limited options.
How similar studies have performed: Other studies have shown promise with similar biologic therapies for Crohn's disease, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 152 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Completed)
- Yale University — New Haven, Connecticut, United States (Completed)
- University of Miami — Miami, Florida, United States (Completed)
- Gastroenterology Group Of Naples — Naples, Florida, United States (Recruiting)
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando — Orlando, Florida, United States (Recruiting)
- Kansas University Medical Center — Kansas City, Kansas, United States (Recruiting)
- University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States (Completed)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Washington University School Of Medicine — Saint Louis, Missouri, United States (Completed)
- Mount Sinai School of Medicine — New York, New York, United States (Recruiting)
- Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States (Completed)
- Gastro One — Germantown, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Completed)
- Tyler Research Institute, LLC — Tyler, Texas, United States (Completed)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
- Flinders Medical Centre — Adelaide, Australia (Recruiting)
- St Vincent's Hospital - Melbourne — Fitzroy, Australia (Recruiting)
- Liverpool Hospital — Liverpool, Australia (Completed)
- Fiona Stanley Hospital — Murdoch, Australia (Recruiting)
- Royal Prince Alfred Hospital — Newtown, Australia (Recruiting)
- Royal Adelaide Hospital — North Terrace, Australia (Recruiting)
- Royal Melbourne Hospital — Parkville, Australia (Recruiting)
- Royal Perth Hospital — Perth, Australia (Recruiting)
- Mater Hospital — South Brisbane, Australia (Recruiting)
- Hopital Erasme — Bruxelles, Belgium (Completed)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Completed)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU Sart Tilman — Liege, Belgium (Recruiting)
- University of Alberta- Ziedler Ledcor Centre — Edmonton, Alberta, Canada (Recruiting)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Completed)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Nemocnice Ceske Budejovice a s — Ceske Budejovice, Czechia (Recruiting)
- ISCARE a.s. — Praha 9, Czechia (Completed)
- Alexandria University Hospital — Alexandria, Egypt (Recruiting)
- National Hepatology and Tropical Medicine Research Institute — Cairo, Egypt (Recruiting)
- Ain Shams University Hospital — Cairo, Egypt (Recruiting)
- Cairo university — Giza, Egypt (Recruiting)
- Clinique Ambroise Pare — Neuilly-sur-Seine, France (Recruiting)
- CHU de Nice Hopital de l Archet — Nice, France (Completed)
- Hopital Saint Joseph — Paris, France (Completed)
- Centre Hospitalier Lyon Sud — Pierre-Benite, France (Recruiting)
- CHRU Hopital de Pontchaillou — Rennes, France (Recruiting)
- CHRU Nancy Brabois — Vandoeuvre les Nancy, France (Recruiting)
- Charite - Campus Mitte — Berlin, Germany (Recruiting)
- JWG-University Hospital — Frankfurt, Germany (Recruiting)
- Universitatsklinikum Schleswig Holstein Kiel — Kiel, Germany (Completed)
- Universitaetsklinikum Mannheim — Mannheim, Germany (Completed)
- Universitaetsklinikum Ulm — Ulm, Germany (Recruiting)
+103 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.