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ACTIVE NOT RECRUITING
NCT05347095
PHASE3

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

Sponsor: Janssen-Cilag Ltd.

View on ClinicalTrials.gov

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

DRUG

Guselkumab

Guselkumab will be administered subcutaneously/IV infusion.

DRUG

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