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
Status: Active_not_recruiting
Location: See all (151) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Connecticut
Yale University
New Haven
Florida
University of Miami
Miami
Gastroenterology Group Of Naples
Naples
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando
Kansas
Kansas University Medical Center
Kansas City
Kentucky
University of Kentucky Chandler Medical Center
Lexington
University of Louisville
Louisville
Missouri
Washington University School Of Medicine
St Louis
New York
Mount Sinai School of Medicine
New York
Oklahoma
Digestive Disease Specialists Inc
Oklahoma City
Tennessee
Gastro One
Germantown
Vanderbilt University Medical Center
Nashville
Texas
Tyler Research Institute, LLC
Tyler
Washington
Swedish Medical Center
Seattle
Other Locations
Australia
Flinders Medical Centre
Adelaide
St Vincent's Hospital - Melbourne
Fitzroy
Liverpool Hospital
Liverpool
Fiona Stanley Hospital
Murdoch
Royal Prince Alfred Hospital
Newtown
Royal Adelaide Hospital
North Terrace
Royal Melbourne Hospital
Parkville
Royal Perth Hospital
Perth
Mater Hospital
South Brisbane
Belgium
Hopital Erasme
Brussels
Ziekenhuis Oost-Limburg
Genk
UZ Leuven
Leuven
CHU Sart Tilman
Liège
Canada
University of Alberta- Ziedler Ledcor Centre
Edmonton
Nova Scotia Health Authority
Halifax
London Health Sciences Centre
London
McGill University Health Centre
Montreal
Mount Sinai Hospital
Toronto
Egypt
Alexandria University Hospital
Alexandria
Ain Shams University Hospital
Cairo
National Hepatology and Tropical Medicine Research Institute
Cairo
Cairo university
Giza
France
Clinique Ambroise Pare
Neuilly-sur-seine
CHU de Nice Hopital de l Archet
Nice
Hopital Saint Joseph
Paris
Centre Hospitalier Lyon Sud
Pierre-bénite
CHRU Hopital de Pontchaillou
Rennes
CHRU Nancy Brabois
Vandœuvre-lès-nancy
Germany
Charite - Campus Mitte
Berlin
JWG-University Hospital
Frankfurt
Universitatsklinikum Schleswig Holstein Kiel
Kiel
Universitaetsklinikum Mannheim
Mannheim
Universitaetsklinikum Ulm
Ulm
Greece
Evangelismos General Hospital of Athens
Athens
Hippokration Hospital
Athens
Sotiria General State Hospital of Chest Diseases
Athens
Alexandra General Hospital of Athens
Athens Attica
University Hospital of Heraklion
Heraklion
University Hospital Of Larissa
Larissa
Patras University Hospital
Pátrai
Hippokration Hospital
Thessaloniki
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest
Semmelweis Egyetem
Budapest
Semmelweis Egyetem
Budapest
Semmelweis Egyetem
Budapest
Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
Pécs
Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
Szeged
Israel
Haemek Medical Center
Afula
Rambam Medical Center
Haifa
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center Beilinson Campus
Petah Tikva
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Negrar ( Ve)
Azienda Ospedaliera Universitaria Pisana
Pisa
Azienda Ospedaliera G.Salvini Ospedale di Rho
Rho
Policlinico Universitario Agostino Gemelli
Roma
Istituto Clinico Humanitas
Rozzano
Casa Sollievo della Sofferenza
San Giovanni Rotondo
Japan
KOKIKAI Tokatsu Tsujinaka Hospital
Abiko
Fukuoka University Chikushi Hospital
Chikushino-shi
Fukuoka University Hospital
Fukuoka
Hospital of the University of Occupational and Enviromental Health
Fukuoka
Kitakyushu Municipal Medical Center
Fukuoka-ken
Hiroshima University Hospital
Hiroshima
Sameshima Hospital
Kagoshima
Nara Medical University Hospital
Kashihara
Tsujinaka Hospital Kashiwanoha
Kashiwa
Nagasaki University Hospital
Nagasaki
Kojunkai Daido Clinic
Nagoya
Nagoya University Hospital
Nagoya
The Hospital of Hyogo College of Medicine
Nishinomiya
Okayama University Hospital
Okayama
Kinshukai Infusion Clinic
Osaka
JOHAS Osaka Rosai Hospital
Sakai
Sapporo Higashi Tokushukai Hospital
Sapporo
Tokyo Yamate Medical Center
Shinjuku-ku
Matsuda Hospital
Shizuoka
Osaka University Hospital
Suita
Kyorin University Hospital
Tokyo
Ieda Hospital
Toyota
Mie University Hospital
Tsu
Yokkaichi Hazu Medical Center
Yokkaichi
Yokohama Municipal Citizen's Hospital
Yokohama
Jordan
Abdali Hospital
Amman
Jordan University Hospital
Amman
The Speciality Hospital (TSH) / Advanced Clinical Center
Amman
Irbid Specialty Hospital
Irbid
King Abdullah University Hospital
Irbid
Netherlands
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam
Radboudumc
Nijmegen
Erasmus MC
Rotterdam
UMC Utrecht
Utrecht
Poland
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok
Centrum Medyczne Promed
Krakow
Centrum Medyczne Med Gastr
Lodz
Centrum Medyczne Medyk
Rzeszów
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
Torun
WIP Warsaw IBD Point Profesor Kierkus
Warsaw
Centrum Medyczne Oporow
Wroclaw
Melita Medical Sp. z o.o.
Wroclaw
Portugal
Uls Braga - Hosp. Braga
Braga
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
Lisbon
H. Santo António - Centro Hospitalar do Porto
Porto
Republic of Korea
Inje University Haeundae Paik Hospital
Busan
Yeungnam University Hospital
Daegu
Seoul National University Bundang Hospital
Gyeonggi-do
Gangnam Severance Hospital, Yonsei University Health System
Seoul
Seoul National University Hospital
Seoul
Saudi Arabia
King Fahad Specialist hospital
Dammam
King Abdulaziz Medical City
Jeddah
King Faisal Specialist Hospital & Research Center
Riyadh
King Saud University Medical City
Riyadh
Spain
Hosp Clinic de Barcelona
Barcelona
Hosp. Arquitecto Marcide
Ferrol
Hosp. Univ. Dr. Josep Trueta
Girona
Hosp. Univ. de La Princesa
Madrid
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda
Hosp. Virgen Macarena
Seville
Hosp. Alvaro Cunqueiro
Vigo
Hosp. Univ. Miguel Servet
Zaragoza
Taiwan
Changhua Christian Hospital
Changhua
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Chang Gung Memorial Hospital Linkou Branch
Taoyuan
Turkey
Gazi University Medical Faculty
Ankara
Acibadem Kozyatagi Hospital
Istanbul
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Ege University Medical Faculty
Izmir
Mersin University Medical Faculty Hospital
Mersin
United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull
Guys and St Thomas NHS Foundation Trust
London
London North West University Healthcare NHS Trust
London
St Georges University Hospital NHS Foundation Trust
London
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
Pennine Acute Hospitals NHS Trust
Salford
Time Frame
Start Date: 2022-09-27
Completion Date: 2027-03-25
Participants
Target number of participants: 288
Treatments
Experimental: Group 1: Guselkumab
Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab.
Experimental: Group 2: Guselkumab
Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.
Experimental: Group 3: Placebo
Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.
Related Therapeutic Areas
Sponsors
Leads: Janssen-Cilag Ltd.