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A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Sponsor: Janssen-Cilag Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2022-09-27
Completion Date
2027-03-25
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Placebo
Matching placebo will be administered subcutaneously/IV infusion.
Locations (153)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, 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
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, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Nemocnice Ceske Budejovice a s
České Budějovice, Czechia
ISCARE a.s.
Prague, Czechia
Alexandria University Hospital
Alexandria, Egypt
National Hepatology and Tropical Medicine Research Institute
Cairo, Egypt
Ain Shams University Hospital
Cairo, Egypt
Cairo university
Giza, Egypt
Clinique Ambroise Pare
Neuilly-sur-Seine, France
CHU de Nice Hopital de l Archet
Nice, France
Hopital Saint Joseph
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHRU Hopital de Pontchaillou
Rennes, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, France
Charite - Campus Mitte
Berlin, Germany
JWG-University Hospital
Frankfurt, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, Germany
Universitaetsklinikum Mannheim
Mannheim, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Evangelismos General Hospital of Athens
Athens, Greece
Hippokration Hospital
Athens, Greece
Sotiria General State Hospital of Chest Diseases
Athens, Greece
Alexandra General Hospital of Athens
Athens Attica, Greece
University Hospital of Heraklion
Heraklion, Greece
University Hospital Of Larissa
Larissa, Greece
Patras University Hospital
Pátrai, Greece
Hippokration Hospital
Thessaloniki, Greece
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
Pécs, Hungary
Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
Szeged, Hungary
Haemek Medical Center
Afula, Israel
Rambam Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Negrar ( Ve), Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Azienda Ospedaliera G.Salvini Ospedale di Rho
Rho, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
KOKIKAI Tokatsu Tsujinaka Hospital
Abiko, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Japan
Kitakyushu Municipal Medical Center
Fukuoka-ken, Japan
Hiroshima University Hospital
Hiroshima, Japan
Sameshima Hospital
Kagoshima, Japan
Nara Medical University Hospital
Kashihara, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Japan
Nagasaki University Hospital
Nagasaki, Japan
Kojunkai Daido Clinic
Nagoya, Japan
Nagoya University Hospital
Nagoya, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Japan
Okayama University Hospital
Okayama, Japan
Kinshukai Infusion Clinic
Osaka, Japan
JOHAS Osaka Rosai Hospital
Sakai, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Japan
Tokyo Yamate Medical Center
Shinjuku-ku, Japan
Matsuda Hospital
Shizuoka, Japan
Osaka University Hospital
Suita, Japan
Kyorin University Hospital
Tokyo, Japan
Ieda Hospital
Toyota, Japan
Mie University Hospital
Tsu, Japan
Yokkaichi Hazu Medical Center
Yokkaichi, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Japan
The Speciality Hospital (TSH) / Advanced Clinical Center
Amman, Jordan
Jordan University Hospital
Amman, Jordan
Abdali Hospital
Amman, Jordan
Irbid Specialty Hospital
Irbid, Jordan
King Abdullah University Hospital
Irbid, Jordan
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, Netherlands
Radboudumc
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok, Poland
Centrum Medyczne Promed
Krakow, Poland
Centrum Medyczne Med Gastr
Lodz, Poland
Centrum Medyczne Medyk
Rzeszów, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Melita Medical Sp. z o.o.
Wroclaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
Uls Braga - Hosp. Braga
Braga, Portugal
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
Lisbon, Portugal
H. Santo António - Centro Hospitalar do Porto
Porto, Portugal
King Fahad Specialist hospital
Dammam, Saudi Arabia
King Abdulaziz Medical City
Jeddah, Saudi Arabia
King Saud University Medical City
Riyadh, Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Inje University Haeundae Paik Hospital
Busan, South Korea
Yeungnam University Hospital
Daegu, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hosp Clinic de Barcelona
Barcelona, Spain
Hosp. Arquitecto Marcide
Ferrol, Spain
Hosp. Univ. Dr. Josep Trueta
Girona, Spain
Hosp. Univ. de La Princesa
Madrid, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, Spain
Hosp. Virgen Macarena
Seville, Spain
Hosp. Alvaro Cunqueiro
Vigo, Spain
Hosp. Univ. Miguel Servet
Zaragoza, Spain
Changhua Christian Hospital
Changhua, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, Taiwan
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Acibadem Kozyatagi Hospital
Istanbul, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Mersin University Medical Faculty Hospital
Mersin, Turkey (Türkiye)
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
London North West University Healthcare NHS Trust
London, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Pennine Acute Hospitals NHS Trust
Salford, United Kingdom