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Clinical Trials in the UK / NCT05347095
Active, not recruiting Phase 3

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

NCT05347095 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen-Cilag Ltd.
Phase
Phase 3
Started
2022-09-27
Last updated
2026-08-28

Condition(s) studied

Fistulizing Crohns DiseasePerianal Crohns Disease

Investigational drug(s) / intervention(s)

GuselkumabPlacebo

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)

Trial sites (154)

FacilityCityRegionStatus
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 the UK

Official registry record

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 the UK