A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
On this site
📄 Tremfya (guselkumab) drug profile →More Janssen-Cilag Ltd. trials in France
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.
View NCT05347095 on ClinicalTrials.gov ↗ ← All trials in France