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My Saved Trials

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

Last Updated   May 9, 2025

Want to learn how to participate in this trial?

CR109189

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    153 Sites
  • Status
    Recruiting

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.

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
* 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:

* Has a very severe luminal disease activity
* 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


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
* Has previousl

More...

DETAILS

LOCATIONS

Locations in:
United States, Australia, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Jordan, South Korea, Netherlands, Poland, Portugal, Saudi Arabia, Spain, Taiwan, Türkiye, United Kingdom, Egypt
Country (23) City or Province (153) Status
United States Birmingham University of Alabama at Birmingham
COMPLETED
United States Naples Gastroenterology Group Of Naples
RECRUITING
United States Orlando AdventHealth Medical Group Blood & Marrow Transplant at Orlando
RECRUITING
United States Kansas City Kansas University Medical Center
RECRUITING
United States Louisville University of Louisville
RECRUITING
United States New York Mount Sinai School of Medicine
RECRUITING
United States Oklahoma City Digestive Disease Specialists Inc
COMPLETED
United States Germantown Gastro One
RECRUITING
United States Tyler Tyler Research Institute, LLC
RECRUITING
United States Seattle Swedish Medical Center
RECRUITING
Australia Adelaide Flinders Medical Centre
RECRUITING
Australia Fitzroy St Vincent's Hospital - Melbourne
RECRUITING
Australia Murdoch Fiona Stanley Hospital
RECRUITING
Australia Newtown Royal Prince Alfred Hospital
RECRUITING
Australia North Terrace Royal Adelaide Hospital
RECRUITING
Australia Parkville Royal Melbourne Hospital
RECRUITING
Australia Perth Royal Perth Hospital
RECRUITING
Australia South Brisbane Mater Hospital
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
Belgium Liege CHU Sart Tilman
RECRUITING
Canada Edmonton University of Alberta- Ziedler Ledcor Centre
RECRUITING
Canada London London Health Sciences Centre
RECRUITING
Canada Toronto Mount Sinai Hospital
RECRUITING
Canada Montreal McGill University Health Centre
RECRUITING
Czechia Ceske Budejovice Nemocnice Ceske Budejovice a s
RECRUITING
France Neuilly-sur-Seine Clinique Ambroise Pare
RECRUITING
France Pierre-Benite Centre Hospitalier Lyon Sud
RECRUITING
France Rennes CHRU Hopital de Pontchaillou
RECRUITING
France Vandoeuvre les Nancy CHRU Nancy Brabois
RECRUITING
Germany Berlin Charite - Campus Mitte
RECRUITING
Germany Frankfurt JWG-University Hospital
RECRUITING
Germany Mannheim Universitaetsklinikum Mannheim
RECRUITING
Greece Athens Evangelismos General Hospital of Athens
RECRUITING
Greece Athens Hippokration Hospital
RECRUITING
Greece Heraklion University Hospital of Heraklion
RECRUITING
Greece Patras Patras University Hospital
RECRUITING
Hungary Budapest Magyar Honvedseg Egeszsegugyi Kozpont
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Israel Haifa Rambam Medical Center
RECRUITING
Israel Jerusalem Shaare Zedek Medical Center
RECRUITING
Israel Petah Tikva Rabin Medical Center Beilinson Campus
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 San Giovanni Rotondo Casa Sollievo della Sofferenza
RECRUITING
Japan Abiko KOKIKAI Tokatsu Tsujinaka Hospital
RECRUITING
Japan Chikushino-shi Fukuoka University Chikushi Hospital
RECRUITING
Japan Fukuoka-ken Kitakyushu Municipal Medical Center
RECRUITING
Japan Hiroshima shi Hiroshima University Hospital
RECRUITING
Japan Kagoshima Sameshima Hospital
RECRUITING
Japan Kashihara Nara Medical University Hospital
RECRUITING
Japan Kashiwa Tsujinaka Hospital Kashiwanoha
RECRUITING
Japan Nagasaki Nagasaki University Hospital
RECRUITING
Japan Nishinomiya The Hospital of Hyogo College of Medicine
RECRUITING
Japan Shinjuku-ku Tokyo Yamate Medical Center
RECRUITING
Japan Shizuoka Matsuda Hospital
RECRUITING
Japan Suita Osaka University Hospital
RECRUITING
Japan Tokyo Kyorin University Hospital
RECRUITING
Japan Toyota Ieda Hospital
RECRUITING
Japan Tsu Mie University Hospital
RECRUITING
Japan Yokkaichi Yokkaichi Hazu Medical Center
RECRUITING
Jordan Amman The Speciality Hospital (TSH) / Advanced Clinical Center
RECRUITING
Jordan Amman Jordan University Hospital
RECRUITING
Jordan Amman Abdali Hospital
RECRUITING
Jordan Irbid Irbid Specialty Hospital
RECRUITING
Jordan Irbid King Abdullah University Hospital
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Netherlands Amsterdam Academisch Medisch Centrum Universiteit van Amsterdam
RECRUITING
Netherlands Nijmegen Radboudumc
RECRUITING
Netherlands Utrecht UMC Utrecht
COMPLETED
Poland Bialystok Gastromed Kralisz Romatowski Stachurska Sp. j.
RECRUITING
Poland Krakow Centrum Medyczne Promed
RECRUITING
Poland Rzeszow Centrum Medyczne Medyk
RECRUITING
Poland Szczecin Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Poland Warszawa WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Poland Wroclaw Melita Medical Sp. z o.o.
RECRUITING
Portugal Porto H. Santo António - Centro Hospitalar do Porto
RECRUITING
Saudi Arabia Dammam King Fahad Specialist hospital
RECRUITING
Saudi Arabia Jeddah King Abdulaziz Medical City
RECRUITING
Saudi Arabia Riyadh King Saud University Medical City
RECRUITING
Saudi Arabia Riyadh King Faisal Specialist Hospital & Research Center
RECRUITING
Spain Barcelona Hosp Clinic de Barcelona
RECRUITING
Spain Ferrol Hosp. Arquitecto Marcide
RECRUITING
Spain Madrid Hosp. Univ. de La Princesa
RECRUITING
Spain Majadahonda Hosp. Univ. Pta. de Hierro Majadahonda
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
Spain Vigo Hosp. Alvaro Cunqueiro
RECRUITING
Spain Zaragoza Hosp. Univ. Miguel Servet
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
Türkiye Ankara Gazi University Medical Faculty
RECRUITING
Türkiye Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Türkiye Istanbul Acibadem Kozyatagi Hospital
RECRUITING
Türkiye İzmir Ege University Medical Faculty
RECRUITING
Türkiye Mersin Mersin University Medical Faculty Hospital
RECRUITING
United Kingdom Hull Hull University Teaching Hospitals NHS 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
United States Saint Louis Washington University School Of Medicine
COMPLETED
Germany Ulm Universitaetsklinikum Ulm
RECRUITING
Japan Nagoya Nagoya University Hospital
RECRUITING
Spain Girona Hosp. Univ. Dr. Josep Trueta
RECRUITING
United States New Haven Yale University
COMPLETED
United States Miami University of Miami
COMPLETED
United States Lexington University of Kentucky Chandler Medical Center
COMPLETED
United States Nashville Vanderbilt University Medical Center
COMPLETED
Australia Liverpool Liverpool Hospital
COMPLETED
Belgium Bruxelles Hopital Erasme
COMPLETED
Belgium Genk Ziekenhuis Oost-Limburg
COMPLETED
Canada Halifax Nova Scotia Health Authority
COMPLETED
Czechia Praha 9 ISCARE a.s.
COMPLETED
Egypt Alexandria Alexandria University Hospital
RECRUITING
Egypt Cairo National Hepatology and Tropical Medicine Research Institute
RECRUITING
Egypt Cairo Ain Shams University Hospital
RECRUITING
Egypt Giza Cairo university
RECRUITING
France Nice CHU de Nice Hopital de l Archet
COMPLETED
France Paris Hopital Saint Joseph
COMPLETED
Germany Kiel Universitatsklinikum Schleswig Holstein Kiel
COMPLETED
Greece Athens Attica Alexandra General Hospital of Athens
RECRUITING
Greece Athens Sotiria General State Hospital of Chest Diseases
RECRUITING
Greece Larissa University Hospital Of Larissa
RECRUITING
Greece Thessaloniki Hippokration Hospital
RECRUITING
Hungary Budapest Semmelweis Egyetem
COMPLETED
Hungary Pecs Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
COMPLETED
Hungary Szeged Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
RECRUITING
Israel Afula Haemek Medical Center
RECRUITING
Italy RHO Azienda Ospedaliera G.Salvini Ospedale di Rho
COMPLETED
Italy Roma Policlinico Universitario Agostino Gemelli
RECRUITING
Italy Rozzano Istituto Clinico Humanitas
RECRUITING
Japan Fukuoka Fukuoka University Hospital
COMPLETED
Japan Hukuoka Hospital of the University of Occupational and Enviromental Health
COMPLETED
Japan Nagoya Kojunkai Daido Clinic
COMPLETED
Japan Okayama Okayama University Hospital
RECRUITING
Japan Osaka Kinshukai Infusion Clinic
COMPLETED
Japan Sakai JOHAS Osaka Rosai Hospital
COMPLETED
Japan Sapporo Sapporo Higashi Tokushukai Hospital
COMPLETED
Japan Yokohama Yokohama Municipal Citizen's Hospital
COMPLETED
South Korea Busan Inje University Haeundae Paik Hospital
COMPLETED
South Korea Daegu Yeungnam University Hospital
COMPLETED
South Korea Gyeonggi-do Seoul National University Bundang Hospital
COMPLETED
Netherlands Rotterdam Erasmus MC
COMPLETED
Poland Lodz Centrum Medyczne Med Gastr
RECRUITING
Poland Torun GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
RECRUITING
Poland Wroclaw Centrum Medyczne Oporow
RECRUITING
Portugal Braga Uls Braga - Hosp. Braga
RECRUITING
Portugal Lisboa Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
COMPLETED
United Kingdom London Guys and St Thomas NHS Foundation Trust
RECRUITING
Show More
Geo Locations

33.52066, -86.80249

26.14234, -81.79596

28.53834, -81.37924

39.11417, -94.62746

38.25424, -85.75941

40.71427, -74.00597

35.46756, -97.51643

35.08676, -89.81009

32.35126, -95.30106

47.60621, -122.33207

-34.92866, 138.59863

-37.79839, 144.97833

-32.06987, 115.83757

-33.89835, 151.17754

-34.9211946, 138.6053204

-37.78333, 144.95

-31.95224, 115.8614

-27.48034, 153.02049

50.87959, 4.70093

50.63373, 5.56749

53.55014, -113.46871

42.98339, -81.23304

43.70011, -79.4163

45.50884, -73.58781

48.97447, 14.47434

48.8846, 2.26965

45.7009, 4.82511

48.11198, -1.67429

48.65, 6.18333

52.52437, 13.41053

50.11552, 8.68417

49.4891, 8.46694

37.97945, 23.71622

37.97945, 23.71622

35.32787, 25.14341

38.24444, 21.73444

47.49801, 19.03991

47.49801, 19.03991

47.49801, 19.03991

32.81841, 34.9885

31.76904, 35.21633

32.08707, 34.88747

45.46427, 9.18951

45.5392619, 10.9543613

43.70853, 10.4036

41.70643, 15.7277

35.86667, 140.01667

33.49631, 130.5156

33.6, 130.41667

34.4, 132.45

31.56667, 130.55

34.50896, 135.7929

35.86224, 139.97732

32.75, 129.88333

34.71562, 135.33199

35.2946, 139.57059

34.98333, 138.38333

34.76143, 135.51567

35.6895, 139.69171

35.08333, 137.15

34.73333, 136.51667

34.96667, 136.61667

31.95522, 35.94503

31.95522, 35.94503

31.95522, 35.94503

32.55556, 35.85

32.55556, 35.85

37.566, 126.9784

37.566, 126.9784

52.37403, 4.88969

51.8425, 5.85278

52.09083, 5.12222

53.13333, 23.16433

50.06143, 19.93658

50.04132, 21.99901

53.42894, 14.55302

52.22977, 21.01178

51.1, 17.03333

41.14961, -8.61099

26.43442, 50.10326

21.54238, 39.19797

24.68773, 46.72185

24.68773, 46.72185

41.38879, 2.15899

43.4896, -8.21942

40.4165, -3.70256

40.47353, -3.87182

37.38283, -5.97317

42.23282, -8.72264

41.65606, -0.87734

24.07327, 120.56276

24.1469, 120.6839

25.04776, 121.53185

24.95233, 121.20193

39.91987, 32.85427

41.01384, 28.94966

41.01384, 28.94966

38.41273, 27.13838

36.79526, 34.61792

53.7446, -0.33525

51.50853, -0.12574

51.50853, -0.12574

54.97328, -1.61396

53.48771, -2.29042

38.62727, -90.19789

48.39841, 9.99155

35.18147, 136.90641

41.98311, 2.82493

41.30815, -72.92816

25.77427, -80.19366

37.98869, -84.47772

36.16589, -86.78444

-33.90011, 150.93328

50.85045, 4.34878

50.965, 5.50082

44.64533, -63.57239

50.08804, 14.42076

31.21564, 29.95527

30.06263, 31.24967

30.06263, 31.24967

30.00808, 31.21093

43.70313, 7.26608

48.85341, 2.3488

54.32133, 10.13489

37.9804964, 23.7561153

37.97945, 23.71622

39.63689, 22.41761

40.64361, 22.93086

47.49801, 19.03991

46.08333, 18.23333

46.253, 20.14824

32.60907, 35.2892

45.53245, 9.0402

41.89193, 12.51133

45.38193, 9.1559

33.6, 130.41667

33.8769595, 130.7131381

35.18147, 136.90641

34.65, 133.93333

34.69374, 135.50218

34.58333, 135.46667

43.06667, 141.35

35.43333, 139.65

35.10278, 129.04028

35.87028, 128.59111

37.58944, 126.76917

51.9225, 4.47917

51.75, 19.46667

53.01375, 18.59814

51.1, 17.03333

41.55032, -8.42005

38.71667, -9.13333

51.50853, -0.12574

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5

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