Guselkumab: Guselkumab will be administered subcutaneously/IV infusion.
Placebo: Matching placebo will be administered subcutaneously/IV infusion.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of Participants who Achieve Combined Fistula Remission at Week 24 — Week 24 Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings \[occurring spontaneously or after gentle finger compression\] and absence of collections greater than (\>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging \[MRI\] results.
Trial sites (154)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Yale University
New Haven
Connecticut
University of Miami
Miami
Florida
Gastroenterology Group Of Naples
Naples
Florida
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando
Florida
Kansas University Medical Center
Kansas City
Kansas
University of Kentucky Chandler Medical Center
Lexington
Kentucky
University of Louisville
Louisville
Kentucky
Washington University School Of Medicine
St Louis
Missouri
Mount Sinai School of Medicine
New York
New York
Digestive Disease Specialists Inc
Oklahoma City
Oklahoma
Gastro One
Germantown
Tennessee
Vanderbilt University Medical Center
Nashville
Tennessee
Tyler Research Institute, LLC
Tyler
Texas
Swedish Medical Center
Seattle
Washington
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
Mater Hospital
South Brisbane
Australia
Hopital Erasme
Brussels
Belgium
Ziekenhuis Oost-Limburg
Genk
Belgium
UZ Leuven
Leuven
Belgium
CHU Sart Tilman
Liège
Belgium
University of Alberta- Ziedler Ledcor Centre
Edmonton
Alberta
Nova Scotia Health Authority
Halifax
Nova Scotia
London Health Sciences Centre
London
Ontario
Mount Sinai Hospital
Toronto
Ontario
McGill University Health Centre
Montreal
Quebec
Nemocnice Ceske Budejovice a s
České Budějovice
Czechia
ISCARE a.s.
Prague
Czechia
Alexandria University Hospital 1
Alexandria
Egypt
Alexandria University Hospital
Alexandria
Egypt
National Hepatology and Tropical Medicine Research Institute
Cairo
Egypt
Ain Shams University Hospital
Cairo
Egypt
Cairo university
Giza
Egypt
+ 114 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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