A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
NCT ID: NCT05347095
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
288 participants
INTERVENTIONAL
2022-09-27
2027-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Placebo
Matching placebo will be administered subcutaneously/IV infusion.
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.
Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Placebo
Matching placebo will be administered subcutaneously/IV infusion.
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.
Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Placebo
Matching placebo will be administered subcutaneously/IV infusion.
Interventions
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Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.
Placebo
Matching placebo will be administered subcutaneously/IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen-Cilag Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag Ltd. Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Ltd.
Locations
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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 Enviromental 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
Countries
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Other Identifiers
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CNTO1959CRD3005
Identifier Type: OTHER
Identifier Source: secondary_id
2021-000491-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504740-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109189
Identifier Type: -
Identifier Source: org_study_id