Study on the Effectiveness and Safety of Guselkumab for Patients with Fistulizing Perianal Crohn’s Disease

1 1

What is this study about?

This clinical trial is focused on studying a condition known as fistulizing perianal Crohn’s disease. This is a type of Crohn’s disease that causes abnormal connections, called fistulas, to form near the anus. The trial will evaluate a treatment called Guselkumab, which is a type of medication known as a monoclonal antibody. This medication is designed to help reduce inflammation and improve symptoms in people with this condition. Participants in the study will receive either Guselkumab or a placebo, which is a substance with no active medication.

The purpose of the study is to assess how effective and safe Guselkumab is for treating fistulizing perianal Crohn’s disease. During the study, participants will receive the treatment over a period of time and will be monitored to see how their condition responds. The study will last for several months, and participants will have regular check-ups to track their progress and any changes in their symptoms.

By the end of the study, researchers aim to determine the proportion of participants who achieve combined fistula remission, meaning a significant improvement in their condition, by Week 24. This information will help in understanding the potential benefits of Guselkumab for people with fistulizing perianal Crohn’s disease and may contribute to future treatment options for this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Crohn’s disease with a minimum duration of at least 3 months and the presence of at least one active draining perianal fistula, confirmed by MRI results.

2 randomization

Participants are randomly assigned to receive either the medication guselkumab or a placebo. This process ensures that the study results are unbiased.

3 treatment phase

During the treatment phase, participants receive guselkumab as a solution for injection in a pre-filled syringe at a concentration of 100 mg/mL. The medication is administered subcutaneously, which means it is injected under the skin.

The frequency and duration of administration are determined by the study protocol, which aims to evaluate the efficacy and safety of the treatment.

4 monitoring and follow-up

Participants are monitored regularly to assess the treatment’s effectiveness and any side effects. This includes clinical evaluations and possibly additional imaging studies.

The primary goal is to determine the proportion of participants who achieve combined fistula remission by Week 24.

5 study completion

The study is estimated to conclude by May 17, 2027. At the end of the study, data collected will be analyzed to evaluate the overall efficacy and safety of guselkumab in treating fistulizing, perianal Crohn’s disease.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have a diagnosis of Crohn’s disease for at least 3 months.
  • Must have at least one active draining perianal fistula (an abnormal connection near the anus that drains fluid) confirmed by an MRI (a type of scan).
  • Must have previously shown no response, lost response, or could not tolerate up to two types of biologic agents (special medications for Crohn’s disease) at approved doses. Alternatively, must have a history of not responding to or tolerating at least one of the following treatments for Crohn’s disease: oral corticosteroids (like budesonide and beclomethasone dipropionate) or immunomodulators (such as AZA, 6-MP, MTX).
  • Must have a history of not responding to or tolerating at least one of the following treatments for fistula: antibiotics (like ciprofloxacin, metronidazole) and/or immunomodulators (such as AZA, 6-MP, MTX).

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre hospitalier universitaire de Liege Liege Belgium
Iscare a.s. Prague Czechia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
Area Sanitaria De Ferrol Ferrol Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Centrum Medyczne Oporow Wroclaw Poland
Centrum Medyczne Med-Gastr Sp. z o.o. Lodz Poland
Hippokration Hospital Athens Greece
Evangelismos S.A. Athens Greece
General University Hospital Of Larissa Larissa Greece
Hospital Unviersitario Miguel Servet Zaragoza Spain
Hospital Universitario Virgen Macarena Sevilla Spain
Melita Medical sp. z o.o. Wroclaw Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
General University Hospital Of Patras Patras Greece
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Gastromed Sp. z o.o. Torun Poland
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
University Of Szeged Szeged Hungary
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Unidade Local de Saúde de São José, E. P. E. Lisbon Portugal
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Gigiszjuc Kucwyzl Rcyjanqvec Svhuvtwyte Sjn jo Bialystok Poland
Hngnwmzv Ukdzhtrwouwse Dv Lt Pnlecoih Madrid Spain
Cdlzcyjo Hzcntlvudhvf Uctrsbblqtjiz Do Vunj Vigo Spain
Lapne Ghmmjir Hgrbzecy Os Axbefn Athens Greece
Avfkhycjq Uow Amsterdam The Netherlands
Schlxdisw Rrbitjv Unszhgicyk Mnavavq Cxlccm Nijmegen The Netherlands
Evwrgfu Uqpkzxmpzlzd Mhxshgy Csfatwy Rtzlintdt (pqxlwqm Mzy Rotterdam The Netherlands
Cnsc Dc Nkuby Vandoeuvre Les Nancy France
Gbcudf Utueumkhkw Fvgogvwrx Frankfurt Germany
Wvq Wfakqh Int Pptjy Pedgehre Ktcwjst Warsaw Poland
Atyqmpz Sdcwi Sdoylzdbc Tcerwtwqkqrg Rzvnysjb Rho Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
07.02.2023
Czechia Czechia
Not recruiting
07.02.2023
France France
Not recruiting
07.02.2023
Germany Germany
Not recruiting
07.02.2023
Greece Greece
Not recruiting
07.02.2023
Hungary Hungary
Not recruiting
07.02.2023
Italy Italy
Not recruiting
07.02.2023
Poland Poland
Not recruiting
07.02.2023
Portugal Portugal
Not recruiting
07.02.2023
Spain Spain
Not recruiting
07.02.2023
The Netherlands The Netherlands
Not recruiting
07.02.2023

Trial locations

Investigated drugs:

Guselkumab is a medication being studied for its effectiveness and safety in treating fistulizing, perianal Crohn’s disease. This condition involves the formation of abnormal connections, or fistulas, near the anus in people with Crohn’s disease. Guselkumab works by targeting specific proteins in the immune system that are involved in inflammation, potentially reducing the symptoms and complications associated with this type of Crohn’s disease.

Crohn’s Disease – Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It can cause a range of symptoms, including abdominal pain, diarrhea, weight loss, and fatigue. The disease is characterized by periods of flare-ups and remission, where symptoms may worsen or improve. In some cases, Crohn’s disease can lead to complications such as strictures, fistulas, and malnutrition. The exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The condition can vary greatly in severity and impact on daily life.

Trial ID:
2023-504740-33-00
Protocol code:
CNTO1959CRD3005
NCT ID:
NCT05347095
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Effectiveness and Safety of RO7790121 for Patients with Moderate to Severe Crohn’s Disease

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia France +8
  • A study testing how well mirikizumab works to achieve transmural healing in patients with Crohn’s Disease

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France