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

Last updated: June 4, 2026
Sponsor: Janssen-Cilag Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Guselkumab

Clinical Study ID

NCT05347095
CR109189
2021-000491-10
CNTO1959CRD3005
2023-504740-33-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Must have a diagnosis of Crohn's disease with a minimum duration of at least 3months

  • Has at least one active draining perianal fistula as a complication of Crohn'sdisease, confirmed by screening magnetic resonance imaging (MRI) results

  • Has previously demonstrated lack of initial response (that is primarynon-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes ofadvanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approvedbiosimilars for these agents) or JAK inhibitors licensed for Crohn's diseasetreatment (that is, upadacitinib)

Exclusion

Exclusion Criteria:

  • Has a very severe luminal disease activity

  • History of concurrent rectovaginal fistulas (other types of concurrent fistulashould be confirmed with the sponsor), rectal and/or anal stenosis, stoma orfunctioning ostomy (include all current stoma types abscess or collections which arenot properly drained) colonic mucosal dysplasia or pre-cancerous lesions that havenot been removed, demyelinating disease, or systemic lupus erythematosus

  • Has complications of CD, such as symptomatic strictures or stenoses, short gutsyndrome, or any other manifestation that might be anticipated to require surgery orpreclude fistula evaluation

  • Any medical contraindications preventing study participation

  • Has a history of ongoing, chronic or recurrent enteral or systemic infectiousdisease

Study Design

Total Participants: 288
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 27, 2022
Estimated Completion Date:
March 25, 2027

Connect with a study center

  • Flinders Medical Centre

    Adelaide, 5042
    Australia

    Site Not Available

  • St Vincent's Hospital - Melbourne

    Fitzroy, 3065
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, 2170
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Newtown, 2042
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    North Terrace, 5000
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, 3050
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, 6000
    Australia

    Site Not Available

  • Mater Hospital

    South Brisbane, 4101
    Australia

    Site Not Available

  • Hopital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg

    Genk, 3600
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • CHU Sart Tilman

    Liège, B-4000
    Belgium

    Site Not Available

  • University of Alberta- Ziedler Ledcor Centre

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H2Y9
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Nemocnice Ceske Budejovice, a.s.

    Ceske Budejovice, 37001
    Czechia

    Active - Recruiting

  • ISCARE a.s.

    Prague, 190 00
    Czechia

    Site Not Available

  • ISCARE a.s.

    Praha 9, 190 00
    Czechia

    Active - Recruiting

  • Nemocnice Ceske Budejovice a s

    České Budějovice, 37001
    Czechia

    Site Not Available

  • Alexandria University Hospital

    Alexandria, 21131
    Egypt

    Site Not Available

  • Alexandria University Hospital 1

    Alexandria, 21131
    Egypt

    Site Not Available

  • Ain Shams University Hospital

    Cairo, 11517
    Egypt

    Site Not Available

  • National Hepatology and Tropical Medicine Research Institute

    Cairo, 11451
    Egypt

    Site Not Available

  • Ain Shams University Hospital

    Cairo 360630, 11517
    Egypt

    Site Not Available

  • Cairo university

    Giza, 12613
    Egypt

    Site Not Available

  • Hopital Beaujon

    Clichy, 92110
    France

    Suspended

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • CHU de Nice Hopital de l Archet

    Nice, 06202
    France

    Site Not Available

  • Hopital Saint Joseph

    Paris, 75014
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • CHRU Hopital de Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

  • Charite - Campus Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Charité - Campus Mitte

    Berlin, 10117
    Germany

    Active - Recruiting

  • JWG-University Hospital

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens, 10676
    Greece

    Site Not Available

  • Hippokration Hospital

    Athens, 11528
    Greece

    Site Not Available

  • Hippokration Hospital 1

    Athens, 11528
    Greece

    Site Not Available

  • Sotiria General State Hospital of Chest Diseases

    Athens, 156 69
    Greece

    Site Not Available

  • Evangelismos General Hospital of Athens

    Athens 264371, 10676
    Greece

    Site Not Available

  • Sotiria General State Hospital of Chest Diseases

    Athens 264371, 156 69
    Greece

    Site Not Available

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28
    Greece

    Site Not Available

  • University Hospital of Heraklion

    Heraklion, 71110
    Greece

    Site Not Available

  • University Hospital Of Larissa

    Larissa, 41110
    Greece

    Site Not Available

  • Patras University Hospital

    Pátrai, 26504
    Greece

    Site Not Available

  • Hippokration Hospital

    Thessaloniki, 54642
    Greece

    Site Not Available

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1082
    Hungary

    Site Not Available

  • Semmelweis Egyetem 1

    Budapest, H-1088
    Hungary

    Site Not Available

  • Semmelweis Egyetem 2

    Budapest, 1083
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest 3054643, 1082
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

    Pecs, 7624
    Hungary

    Active - Recruiting

  • Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

    Pécs, 7624
    Hungary

    Site Not Available

  • Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp

    Szeged, 6725
    Hungary

    Site Not Available

  • Haemek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center, Beilinson Campus

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

    Negrar ( Ve), 37024
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • Azienda Ospedaliera G.Salvini Ospedale di Rho

    Rho,
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • KOKIKAI Tokatsu Tsujinaka Hospital

    Abiko, 270-1168
    Japan

    Site Not Available

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka, 814 0180
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, 807-8555
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka 1863967, 814 0180
    Japan

    Site Not Available

  • Kitakyushu Municipal Medical Center

    Fukuoka-ken, 802-0077
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima, 734 8551
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Enviromental Health

    Hukuoka, 807-8555
    Japan

    Completed

  • Hospital of the University of Occupational and Environmental Health

    Hukuoka, 807-8555
    Japan

    Active - Recruiting

  • Sameshima Hospital

    Kagoshima, 892-0846
    Japan

    Site Not Available

  • Nara Medical University Hospital

    Kashihara, 634-8521
    Japan

    Site Not Available

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871
    Japan

    Site Not Available

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • Kojunkai Daido Clinic

    Nagoya, 457-8511
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya, 466 8560
    Japan

    Site Not Available

  • Kojunkai Daido Clinic

    Nagoya 1856057, 457-8511
    Japan

    Site Not Available

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700 8558
    Japan

    Site Not Available

  • Kinshukai Infusion Clinic

    Osaka, 530-0011
    Japan

    Site Not Available

  • JOHAS Osaka Rosai Hospital

    Sakai, 591-8025
    Japan

    Site Not Available

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033
    Japan

    Site Not Available

  • Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073
    Japan

    Site Not Available

  • Matsuda Hospital

    Shizuoka, 432-8061
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita, 565 0871
    Japan

    Site Not Available

  • Kyorin University Hospital

    Tokyo, 181 8611
    Japan

    Site Not Available

  • Tokyo Yamate Medical Center

    Tokyo, 169-0073
    Japan

    Active - Recruiting

  • Ieda Hospital

    Toyota, 470-1219
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, 514 8507
    Japan

    Site Not Available

  • Yokkaichi Hazu Medical Center

    Yokkaichi, 510-0016
    Japan

    Site Not Available

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221 0855
    Japan

    Site Not Available

  • Abdali Hospital

    Amman,
    Jordan

    Site Not Available

  • Jordan University Hospital

    Amman, 11942
    Jordan

    Site Not Available

  • The Speciality Hospital (TSH) / Advanced Clinical Center

    Amman, 11194
    Jordan

    Site Not Available

  • Abdali Hospital

    Amman 250441,
    Jordan

    Site Not Available

  • Jordan University Hospital

    Amman 250441, 11942
    Jordan

    Site Not Available

  • Irbid Specialty Hospital

    Irbid, 21110
    Jordan

    Site Not Available

  • King Abdullah University Hospital

    Irbid, 22110
    Jordan

    Site Not Available

  • Irbid Specialty Hospital

    Irbid 248946, 21110
    Jordan

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Hospital

    Daegu, 42415
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Radboudumc

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Gastromed Kralisz Romatowski Stachurska Sp. j.

    Bialystok, 15-322
    Poland

    Site Not Available

  • Centrum Medyczne Promed

    Krakow, 31-513
    Poland

    Site Not Available

  • Centrum Medyczne Med Gastr

    Lodz, 91 034
    Poland

    Site Not Available

  • Centrum Medyczne Med-Gastr

    Lodz, 91-034
    Poland

    Active - Recruiting

  • Centrum Medyczne Medyk

    Rzeszow, 35-326
    Poland

    Active - Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, 35-326
    Poland

    Site Not Available

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434
    Poland

    Site Not Available

  • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87 100
    Poland

    Site Not Available

  • GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87-100
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Active - Recruiting

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Melita Medical Sp. z o.o.

    Wroclaw, 50-449
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw 3081368, 52-416
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wrocław, 52-416
    Poland

    Active - Recruiting

  • Ccab - Hosp. de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Uls Braga - Hosp. Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Chlc - Hosp. Sto Antonio Dos Capuchos

    Lisboa, G1R 2J6
    Portugal

    Active - Recruiting

  • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

    Lisbon, G1R 2J6
    Portugal

    Site Not Available

  • H. Santo António - Centro Hospitalar do Porto

    Porto, 4099-001
    Portugal

    Site Not Available

  • King Fahad Specialist hospital

    Dammam, 31444
    Saudi Arabia

    Site Not Available

  • King Abdulaziz Medical City

    Jeddah, 21423
    Saudi Arabia

    Site Not Available

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 12713
    Saudi Arabia

    Site Not Available

  • King Saud University Medical City

    Riyadh, 11472
    Saudi Arabia

    Site Not Available

  • King Saud University Medical City

    Riyadh 108410, 11472
    Saudi Arabia

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    South Korea

    Site Not Available

  • Yeungnam University Hospital

    Daegu, 42415
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    South Korea

    Site Not Available

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Site Not Available

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul 1835848, 06273
    South Korea

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Arquitecto Marcide

    Ferrol, 15405
    Spain

    Site Not Available

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hosp. Univ. de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009
    Spain

    Site Not Available

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312
    Spain

    Site Not Available

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Changhua Christian Hospital

    Changhua, 500
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei City, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Acibadem Kozyatagi Hospital

    Istanbul, 34734
    Turkey

    Active - Recruiting

  • Gazi University Medical Faculty

    Ankara, 06560
    Turkey (Türkiye)

    Site Not Available

  • Acibadem Kozyatagi Hospital

    Istanbul, 34734
    Turkey (Türkiye)

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098
    Turkey (Türkiye)

    Site Not Available

  • Acibadem Kozyatagi Hospital

    Istanbul 745044, 34734
    Turkey (Türkiye)

    Site Not Available

  • Ege University Medical Faculty

    Izmir, 35100
    Turkey (Türkiye)

    Site Not Available

  • Mersin University Medical Faculty Hospital

    Mersin, 33110
    Turkey (Türkiye)

    Site Not Available

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Guys and St Thomas NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • London North West University Healthcare NHS Trust

    London, HA1 3UJ
    United Kingdom

    Site Not Available

  • St George's University Hospital NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • St Georges University Hospital NHS Foundation Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • London North West University Healthcare NHS Trust

    London 2643743, HA1 3UJ
    United Kingdom

    Site Not Available

  • St Georges University Hospital NHS Foundation Trust

    London 2643743, SW17 0QT
    United Kingdom

    Site Not Available

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE3 3HD
    United Kingdom

    Site Not Available

  • Pennine Acute Hospitals NHS Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Gastroenterology Group Of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando

    Orlando, Florida 32804
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Washington University School Of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.