A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (FUZION CD)

Last Updated   April 24, 2024 - 21:02

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    133 sites
  • Status
    Recruiting

SUMMARY

Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).

CONDITIONS

  • Fistulizing Crohns Disease
  • Perianal Crohns Disease

ELIGIBILITY

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

* Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)

Exclusion Criteria:

* Has a very severe luminal disease activity

* History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease

* 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

DETAILS

Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).

LOCATIONS

Locations in:
United States, United Kingdom, Turkey, Taiwan, Spain, South Korea, Saudi Arabia, Portugal, Poland, Netherlands, Jordan, Japan, Italy, Israel, Hungary, Greece, Germany, France, Czechia, Canada, Belgium, Australia
Country (22) City or Province (133) Status
United States Birmingham, AL University of Alabama at Birmingham
RECRUITING
United States Germantown, TN Gastro One
RECRUITING
United States Kansas City, KS Kansas University Medical Center
RECRUITING
United States Lexington, KY University of Kentucky Chandler Medical Center
RECRUITING
United States Louisville, KY University of Louisville
RECRUITING
United States Miami, FL University of Miami
RECRUITING
United States Naples, FL Gastroenterology Group Of Naples
RECRUITING
United States Nashville, TN Vanderbilt University Medical Center
RECRUITING
United States New Haven, CT Yale University
RECRUITING
United States New York, NY Mount Sinai School of Medicine
RECRUITING
United States Oklahoma City, OK Digestive Disease Specialists Inc
RECRUITING
United States Orlando, FL AdventHealth Medical Group Blood & Marrow Transplant at Orlando
RECRUITING
United States Saint Louis, MO Washington University School of Medicine
RECRUITING
United States Seattle, WA Swedish Medical Center
RECRUITING
United States Tyler, TX Tyler Research Institute, LLC
RECRUITING
United Kingdom Hull Hull University Teaching Hospitals NHS Trust
RECRUITING
United Kingdom London Guy's and St Thomas' NHS Foundation Trust
RECRUITING
United Kingdom London London North West University Healthcare NHS Trust
RECRUITING
United Kingdom London St George's University Hospital NHS Foundation Trust
RECRUITING
United Kingdom Newcastle Upon Tyne Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
United Kingdom Salford Pennine Acute Hospitals NHS Trust
RECRUITING
Turkey Ankara Gazi University Medical Faculty
RECRUITING
Turkey Istanbul Acibadem Kozyatagi Hospital
RECRUITING
Turkey Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Turkey Mersin Mersin University Medical Faculty Hospital
RECRUITING
Turkey İzmir Ege University Medical Faculty
RECRUITING
Taiwan Changhua Changhua Christian Hospital
RECRUITING
Taiwan Taichung Taichung Veterans General Hospital
RECRUITING
Taiwan Taipei City National Taiwan University Hospital
RECRUITING
Taiwan Taoyuan City Chang Gung Memorial Hospital Linkou Branch
RECRUITING
Spain Barcelona, BA Hosp. Clinic de Barcelona
RECRUITING
Spain Ferrol Hosp. Arquitecto Marcide
RECRUITING
Spain Madrid, MD Hosp. Univ. de La Princesa
RECRUITING
Spain Majadahonda, MD Hosp. Univ. Pta. de Hierro Majadahonda
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Vigo, PO Hosp. Alvaro Cunqueiro
RECRUITING
Spain Zaragoza, ZR Hosp. Univ. Miguel Servet
RECRUITING
South Korea Busan Inje University Haeundae Paik Hospital
RECRUITING
South Korea Daegu Yeungnam University Hospital
RECRUITING
South Korea Gyeonggi-do, 41 Seoul National University Bundang Hospital
RECRUITING
South Korea Seoul Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
Saudi Arabia Dammam King Fahad Specialist hospital
RECRUITING
Saudi Arabia Jeddah King Abdulaziz Medical City
RECRUITING
Saudi Arabia Riyadh King Faisal Specialist Hospital & Research Center
RECRUITING
Saudi Arabia Riyadh King Saud University Medical City
RECRUITING
Portugal Braga, Braga Ccab - Hosp. de Braga
RECRUITING
Portugal Lisboa Chlc - Hosp. Sto Antonio Dos Capuchos
RECRUITING
Portugal Porto H. Santo António - Centro Hospitalar do Porto
RECRUITING
Poland Bialystok Gastromed Kralisz Romatowski Stachurska Sp. j.
RECRUITING
Poland Krakow Centrum Medyczne Promed
RECRUITING
Poland Lodz Centrum Medyczne Med-Gastr
RECRUITING
Poland Rzeszow Centrum Medyczne Medyk
RECRUITING
Poland Szczecin Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Poland Torun GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii
RECRUITING
Poland Warszawa WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Poland Wroclaw Melita Medical Sp. z o.o.
RECRUITING
Poland Wrocław Centrum Medyczne Oporow
RECRUITING
Netherlands Amsterdam Academisch Medisch Centrum Universiteit van Amsterdam
RECRUITING
Netherlands Nijmegen, GE Radboudumc
RECRUITING
Netherlands Utrecht, UT UMC Utrecht
RECRUITING
Jordan Amman Abdali Hospital
RECRUITING
Jordan Amman Jordan University Hospital
RECRUITING
Jordan Amman The Speciality Hospital (TSH) / Advanced Clinical Center
RECRUITING
Jordan Irbid Irbid Specialty Hospital
RECRUITING
Jordan Irbid King Abdullah University Hospital
RECRUITING
Japan Abiko KOKIKAI Tokatsu Tsujinaka Hospital
RECRUITING
Japan Chikushino-shi Fukuoka University Chikushi Hospital
RECRUITING
Japan Fukuoka Fukuoka University Hospital
RECRUITING
Japan Fukuoka-ken Kitakyushu Municipal Medical Center
RECRUITING
Japan Hiroshima shi Hiroshima University Hospital
RECRUITING
Japan Hukuoka Hospital of the University of Occupational and Environmental Health
RECRUITING
Japan Kagoshima Sameshima Hospital
RECRUITING
Japan Kashihara, 29 Nara Medical University Hospital
RECRUITING
Japan Kashiwa Tsujinaka Hospital Kashiwanoha
RECRUITING
Japan Nagasaki, 42 Nagasaki University Hospital
RECRUITING
Japan Nagoya Kojunkai Daido Clinic
RECRUITING
Japan Nagoya Nagoya University Hospital
RECRUITING
Japan Nishinomiya, 28 The Hospital of Hyogo College of Medicine
RECRUITING
Japan Okayama, 33 Okayama University Hospital
RECRUITING
Japan Osaka, 27 Kinshukai Infusion Clinic
RECRUITING
Japan Sakai, 27 JOHAS Osaka Rosai Hospital
RECRUITING
Japan Sapporo, 01 Sapporo Higashi Tokushukai Hospital
RECRUITING
Japan Shinjuku-ku, 13 Tokyo Yamate Medical Center
RECRUITING
Japan Shizuoka Matsuda Hospital
RECRUITING
Japan Suita, 27 Osaka University Hospital
RECRUITING
Japan Tokyo, 13 Kyorin University Hospital
RECRUITING
Japan Toyota Ieda Hospital
RECRUITING
Japan Tsu Mie University Hospital
RECRUITING
Japan Yokkaichi, 24 Yokkaichi Hazu Medical Center
RECRUITING
Japan Yokohama, 14 Yokohama Municipal Citizens Hospital
RECRUITING
Italy Milano Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
RECRUITING
Italy Negrar ( Ve) Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
RECRUITING
Italy Pisa Azienda Ospedaliera Universitaria Pisana
RECRUITING
Italy RHO Azienda Ospedaliera G.Salvini Ospedale di Rho
RECRUITING
Italy San Giovanni Rotondo Casa Sollievo della Sofferenza
RECRUITING
Israel Haifa, H Rambam Medical Center
RECRUITING
Israel Jerusalem Shaare Zedek Medical Center
RECRUITING
Israel Petah Tikva Rabin Medical Center Beilinson Campus
RECRUITING
Hungary Budapest Magyar Honvedseg Egeszsegugyi Kozpont
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Hungary Pecs Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
RECRUITING
Greece Athens Evangelismos General Hospital of Athens
RECRUITING
Greece Athens Hippokration Hospital
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Greece Heraklion University Hospital of Heraklion
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Greece Patras Patras University Hospital
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Germany Berlin, BE Charite - Campus Mitte
RECRUITING
Germany Frankfurt, HE JWG-University Hospital
RECRUITING
Germany Kiel, SH Universitatsklinikum Schleswig Holstein Kiel
RECRUITING
Germany Mannheim, BW Universitaetsklinikum Mannheim
RECRUITING
France Neuilly-sur-Seine Clinique Ambroise Pare
RECRUITING
France Nice CHU de Nice Hopital de l Archet
RECRUITING
France Pierre-Benite Centre Hospitalier Lyon Sud
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France Rennes CHRU Hopital de Pontchaillou
RECRUITING
France Vandoeuvre-les-Nancy CHRU Nancy-Brabois
RECRUITING
Czechia Ceske Budejovice Nemocnice Ceske Budejovice, a.s.
RECRUITING
Czechia Praha 9 ISCARE a.s.
RECRUITING
Canada London, ON London Health Sciences Centre
RECRUITING
Canada Montreal, QC McGill University Health Centre
RECRUITING
Canada Toronto, ON Mount Sinai Hospital
RECRUITING
Belgium Bruxelles, BRU Hopital Erasme
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
Belgium Liege CHU Sart Tilman
RECRUITING
Australia Adelaide, SA Flinders Medical Centre
RECRUITING
Australia Fitzroy, VIC St Vincent's Hospital - Melbourne
RECRUITING
Australia Liverpool, NSW Liverpool Hospital
RECRUITING
Australia Murdoch, WA Fiona Stanley Hospital
RECRUITING
Australia Newtown, NSW Royal Prince Alfred Hospital
RECRUITING
Australia North Terrace, SA Royal Adelaide Hospital
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Australia Parkville, VIC Royal Melbourne Hospital
RECRUITING
Australia Perth, WA Royal Perth Hospital
RECRUITING
Australia South Brisbane, QLD Mater Hospital
RECRUITING
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