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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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).
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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.

What is already known about the treatment

Guselkumab – Guselkumab is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating fistulizing perianal Crohn's disease. It is a monoclonal antibody that targets interleukin-23 (IL-23), a protein involved in inflammatory processes. By inhibiting IL-23, guselkumab helps reduce inflammation and manage symptoms associated with Crohn's disease. It is classified as an immunosuppressive agent and is already approved for use in other inflammatory conditions, such as psoriasis.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504740-33-00Protocol codeCNTO1959CRD3005Estimated enrolment280 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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