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Study on Guselkumab for Healing in Crohn's Disease Patients

Fast replyInvestigationalNo placebo
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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 Crohn's Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The treatment being tested in this study is called Guselkumab, which is a medication given as a solution for injection or infusion. It is designed to help reduce inflammation and promote healing in the intestines.

The purpose of the study is to evaluate how effective Guselkumab is in achieving healing of the intestinal walls in patients with Crohn's Disease. Participants in the study will receive the medication over a period of time, and their progress will be monitored to see if there is improvement in their condition. The study will involve regular check-ups and assessments to track the healing process and any changes in symptoms.

Throughout the study, some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Guselkumab. The study aims to provide valuable information on the potential benefits of this treatment for individuals with Crohn's Disease, contributing to better management of the condition in the future.

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 will be conducted to confirm eligibility. This includes reviewing medical history and current health status related to Crohn's Disease.

    Eligibility is based on specific criteria, such as having active Crohn's Disease for at least 3 months and a certain level of disease activity.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of guselkumab, a medication used to manage Crohn's Disease.

    Initially, guselkumab will be given as a solution for infusion, which means it will be administered directly into a vein.

  3. Step 3

    Ongoing treatment

    After the initial infusion, guselkumab will be administered as a solution for injection using a pre-filled syringe. This is done subcutaneously, meaning it is injected under the skin.

    The frequency and dosage of the injections will be determined by the study protocol and medical team.

  4. Step 4

    Regular monitoring

    Throughout the study, regular monitoring will occur to assess the effectiveness of the treatment and any side effects.

    This includes periodic evaluations using imaging techniques to measure the healing of the intestinal lining.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall impact of guselkumab on Crohn's Disease.

    The primary goal is to determine if there is significant healing of the intestinal lining after 48 weeks of treatment.

Who can join the trial?

5 criteria

  • Must have been diagnosed with Crohn's Disease for at least 3 months. This means having inflammation in the digestive tract, confirmed by tests like X-rays, tissue samples, or a camera exam.
  • Must have clinically active Crohn's Disease, which means having a certain level of symptoms. This includes a specific score on a test called the Crohn's Disease Activity Index (CDAI), which should be between 220 and 450. Additionally, either having an average of 4 or more very soft or liquid stools per day or having an average abdominal pain score of 2 or more.
  • Must have active inflammation in at least one part of the digestive tract, shown by a test called MaRIA with a score of 11 or higher.
  • Must have tried standard treatments for Crohn's Disease and either not responded well, stopped responding over time, or could not tolerate them. This includes having issues with up to one type of advanced treatment, such as certain medications like JAK inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or their approved similar versions.
  • Both males and females can participate.

Who cannot join the trial?

12 criteria

  • Patients with any other significant health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have a history of liver disease or liver problems.
  • Patients who have a history of tuberculosis (TB) or have been in close contact with someone with TB.
  • Patients who have received certain vaccines within a specific time frame before the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have had a major surgery within a specific time frame before the study.
  • Patients who have a known allergy to the study medication or its ingredients.
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Investigated drugs

Guselkumab is a medication used in this clinical trial to help treat Crohn's Disease. It works by targeting specific proteins in the body that are involved in inflammation. By doing this, it aims to reduce the inflammation in the intestines, which is a common problem for people with Crohn's Disease. The goal of using Guselkumab in this study is to see if it can help heal the intestines and improve the overall condition of patients with this disease over time.

What is already known about the treatment

Guselkumab – Guselkumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating Crohn's Disease, a condition that causes inflammation of the digestive tract. The medication works by targeting a specific protein in the body called interleukin-23 (IL-23), which plays a role in inflammation. By blocking this protein, guselkumab helps reduce inflammation and may promote healing in the intestines. It is classified as a biologic medication, which means it is made from living cells.

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 is characterized by inflammation that can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, diarrhea, and weight loss. The disease often progresses with periods of remission and flare-ups, where symptoms can become more severe. Over time, the inflammation can cause complications like strictures, fistulas, and malabsorption of nutrients. The exact cause of Crohn's Disease is unknown, but it involves an abnormal immune response to intestinal bacteria. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504040-34-01Protocol codeCNTO1959CRD3008Estimated enrolment186 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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