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New drug shows promise for healing Crohn's fistulas

NCT ID NCT05347095

Disease control Sponsor: Janssen-Cilag Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a drug called guselkumab in people with Crohn's disease who have abnormal tunnels (fistulas) near the anus. The goal is to see if the drug can close these fistulas and prevent new ones, using MRI scans to confirm healing. About 288 adults who have not responded to other treatments will receive either guselkumab or a placebo, and their progress will be tracked for up to 48 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

288 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease perianal Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fistulizing crohns disease Perianal crohns disease

Contacts and locations

Locations

  • Abdali Hospital

    Amman, Jordan

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 1105 AZ, Netherlands

  • Acibadem Kozyatagi Hospital

    Istanbul, 34734, Turkey (Türkiye)

  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando

    Orlando, Florida, 32804, United States

  • Ain Shams University Hospital

    Cairo, 11517, Egypt

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28, Greece

  • Alexandria University Hospital

    Alexandria, 21131, Egypt

  • Alexandria University Hospital 1

    Alexandria, 21131, Egypt

  • Azienda Ospedaliera G.Salvini Ospedale di Rho

    Rho, Italy

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124, Italy

  • CHRU Hopital de Pontchaillou

    Rennes, 35033, France

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHU Sart Tilman

    Liège, B-4000, Belgium

  • CHU de Nice Hopital de l Archet

    Nice, 06202, France

  • Cairo university

    Giza, 12613, Egypt

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centrum Medyczne Med Gastr

    Lodz, 91 034, Poland

  • Centrum Medyczne Medyk

    Rzeszów, 35-326, Poland

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Centrum Medyczne Promed

    Krakow, 31-513, Poland

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan City, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Charite - Campus Mitte

    Berlin, 10117, Germany

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200, France

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112, United States

  • Ege University Medical Faculty

    Izmir, 35100, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Evangelismos General Hospital of Athens

    Athens, 10676, Greece

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Flinders Medical Centre

    Adelaide, 5042, Australia

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502, Japan

  • Fukuoka University Hospital

    Fukuoka, 814 0180, Japan

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

    Torun, 87 100, Poland

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273, South Korea

  • Gastro One

    Germantown, Tennessee, 38138, United States

  • Gastroenterology Group Of Naples

    Naples, Florida, 34102, United States

  • Gastromed Kralisz Romatowski Stachurska Sp. j.

    Bialystok, 15-322, Poland

  • Gazi University Medical Faculty

    Ankara, 06560, Turkey (Türkiye)

  • Guys and St Thomas NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • H. Santo António - Centro Hospitalar do Porto

    Porto, 4099-001, Portugal

  • Haemek Medical Center

    Afula, 1834111, Israel

  • Hippokration Hospital

    Thessaloniki, 54642, Greece

  • Hippokration Hospital 1

    Athens, 11528, Greece

  • Hiroshima University Hospital

    Hiroshima, 734 8551, Japan

  • Hopital Erasme

    Brussels, 1070, Belgium

  • Hopital Saint Joseph

    Paris, 75014, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312, Spain

  • Hosp. Arquitecto Marcide

    Ferrol, 15405, Spain

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007, Spain

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009, Spain

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hosp. Univ. de La Princesa

    Madrid, 28006, Spain

  • Hosp. Virgen Macarena

    Seville, 41009, Spain

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, 807-8555, Japan

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ, United Kingdom

  • ISCARE a.s.

    Prague, 190 00, Czechia

  • Ieda Hospital

    Toyota, 470-1219, Japan

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Irbid Specialty Hospital

    Irbid, 21110, Jordan

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • JOHAS Osaka Rosai Hospital

    Sakai, 591-8025, Japan

  • JWG-University Hospital

    Frankfurt, 60590, Germany

  • Jordan University Hospital

    Amman, 11942, Jordan

  • KOKIKAI Tokatsu Tsujinaka Hospital

    Abiko, 270-1168, Japan

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • King Abdulaziz Medical City

    Jeddah, 21423, Saudi Arabia

  • King Abdullah University Hospital

    Irbid, 22110, Jordan

  • King Fahad Specialist hospital

    Dammam, 31444, Saudi Arabia

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 12713, Saudi Arabia

  • King Saud University Medical City

    Riyadh, 11472, Saudi Arabia

  • Kinshukai Infusion Clinic

    Osaka, 530-0011, Japan

  • Kitakyushu Municipal Medical Center

    Fukuoka-ken, 802-0077, Japan

  • Kojunkai Daido Clinic

    Nagoya, 457-8511, Japan

  • Kyorin University Hospital

    Tokyo, 181 8611, Japan

  • Liverpool Hospital

    Liverpool, 2170, Australia

  • London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

  • London North West University Healthcare NHS Trust

    London, HA1 3UJ, United Kingdom

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062, Hungary

  • Mater Hospital

    South Brisbane, 4101, Australia

  • Matsuda Hospital

    Shizuoka, 432-8061, Japan

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4, Canada

  • Melita Medical Sp. z o.o.

    Wroclaw, 50-449, Poland

  • Mersin University Medical Faculty Hospital

    Mersin, 33110, Turkey (Türkiye)

  • Mie University Hospital

    Tsu, 514 8507, Japan

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Nagoya University Hospital

    Nagoya, 466 8560, Japan

  • Nara Medical University Hospital

    Kashihara, 634-8521, Japan

  • National Hepatology and Tropical Medicine Research Institute

    Cairo, 11451, Egypt

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nemocnice Ceske Budejovice a s

    České Budějovice, 37001, Czechia

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE3 3HD, United Kingdom

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H2Y9, Canada

  • Okayama University Hospital

    Okayama, 700 8558, Japan

  • Osaka University Hospital

    Suita, 565 0871, Japan

  • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

    Negrar ( Ve), 37024, Italy

  • Patras University Hospital

    Pátrai, 26504, Greece

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

    Pécs, 7624, Hungary

  • Pennine Acute Hospitals NHS Trust

    Salford, M6 8HD, United Kingdom

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100, Israel

  • Radboudumc

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Royal Adelaide Hospital

    North Terrace, 5000, Australia

  • Royal Melbourne Hospital

    Parkville, 3050, Australia

  • Royal Perth Hospital

    Perth, 6000, Australia

  • Royal Prince Alfred Hospital

    Newtown, 2042, Australia

  • Sameshima Hospital

    Kagoshima, 892-0846, Japan

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033, Japan

  • Semmelweis Egyetem

    Budapest, 1082, Hungary

  • Semmelweis Egyetem 1

    Budapest, H-1088, Hungary

  • Semmelweis Egyetem 2

    Budapest, 1083, Hungary

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sotiria General State Hospital of Chest Diseases

    Athens, 156 69, Greece

  • St Georges University Hospital NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • St Vincent's Hospital - Melbourne

    Fitzroy, 3065, Australia

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp

    Szeged, 6725, Hungary

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501, Japan

  • The Speciality Hospital (TSH) / Advanced Clinical Center

    Amman, 11194, Jordan

  • Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073, Japan

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871, Japan

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434, Poland

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701, United States

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uls Braga - Hosp. Braga

    Braga, 4710-243, Portugal

  • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

    Lisbon, G1R 2J6, Portugal

  • Universitaetsklinikum Mannheim

    Mannheim, 68167, Germany

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105, Germany

  • University Hospital Of Larissa

    Larissa, 41110, Greece

  • University Hospital of Heraklion

    Heraklion, 71110, Greece

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Alberta- Ziedler Ledcor Centre

    Edmonton, Alberta, T6G 2X8, Canada

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728, Poland

  • Washington University School Of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

  • Yeungnam University Hospital

    Daegu, 42415, South Korea

  • Yokkaichi Hazu Medical Center

    Yokkaichi, 510-0016, Japan

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221 0855, Japan

  • Ziekenhuis Oost-Limburg

    Genk, 3600, Belgium

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