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Study on Tulisokibart for Treating Moderate to Severe Crohn's Disease in Adults

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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 study is testing a new treatment called tulisokibart, which is being developed by Merck & Co. Inc. The treatment is administered either as a concentrate for solution for infusion or as a solution for injection using a pre-filled injector. The study also includes a comparison with a placebo to evaluate the effectiveness of tulisokibart.

The purpose of the study is to assess how well tulisokibart works in helping patients achieve clinical remission, which means a reduction or disappearance of the symptoms of Crohn's Disease. Participants will receive either tulisokibart or a placebo and will be monitored over a period of time to see if their symptoms improve. The study will look at various measures, including the frequency of bowel movements and abdominal pain, to determine the treatment's effectiveness.

Participants in the study will be observed for up to 52 weeks, with assessments at different points to track their progress. The study aims to provide valuable information on whether tulisokibart can be a safe and effective treatment option for people with moderately to severely active Crohn's Disease. The results will help determine if tulisokibart can help patients achieve a better quality of life by managing their symptoms more effectively.

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 the diagnosis of Crohn's Disease and ensuring it has been present for at least three months. The assessment will also verify that the disease is moderately to severely active.

    The assessment will check for previous inadequate responses or intolerance to certain medications, such as oral steroids, systemic steroids, immunomodulators, or advanced therapies.

  2. Step 2

    Randomization

    Participants will be randomly assigned to receive either the study medication, tulisokibart, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  3. Step 3

    Treatment administration

    The study medication, tulisokibart, will be administered in two forms: as an intravenous infusion or as a subcutaneous injection. The specific dosage and frequency will be determined by the study protocol.

    Participants will receive the treatment over a period of 52 weeks, with regular monitoring and assessments throughout the study duration.

  4. Step 4

    Regular assessments

    Throughout the study, participants will undergo regular assessments to monitor the effectiveness of the treatment. These assessments will include evaluations of clinical remission using the Crohn's Disease Activity Index and other measures such as stool frequency and abdominal pain scores.

    Assessments will occur at specific intervals, including at weeks 12 and 52, to evaluate the progress and response to the treatment.

  5. Step 5

    End of study evaluation

    At the end of the 52-week period, a final evaluation will be conducted to assess the overall effectiveness and safety of the treatment. This will include a comprehensive review of all collected data and any changes in the participant's condition.

    Participants will be informed of the study results and any potential next steps following the conclusion of the trial.

Who can join the trial?

8 criteria

  • Must have been diagnosed with Crohn's Disease at least 3 months before joining the study.
  • Must have moderately to severely active Crohn's Disease. This means the disease is not mild and needs more treatment.
  • Must have tried and not responded well, or stopped responding, or could not tolerate one or more of the following types of medications:
    • Oral locally acting steroids: These are medicines taken by mouth that target specific areas in the digestive system.
    • Systemic steroids: These are medicines that affect the whole body to reduce inflammation.
    • Immunomodulators: These are medicines that help to regulate or normalize the immune system.
    • Biologic and/or small molecule advanced therapies: These are newer types of treatments that target specific parts of the immune system.
    • Both male and female participants can join the study.
    • Participants must be within the specified age range for the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have Crohn's Disease cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Tulisokibart is a medication being studied for its potential to help people with Crohn's Disease, which is a condition that causes inflammation in the digestive tract. The goal of using tulisokibart in this clinical trial is to see if it can help reduce the symptoms of Crohn's Disease, such as frequent bowel movements and abdominal pain, and to see if it can help achieve clinical remission. Clinical remission means that the symptoms of the disease are reduced or disappear. The trial is also looking at whether tulisokibart can help improve the appearance of the digestive tract when viewed with a special camera, which is known as an endoscopic response. This medication is being compared to a placebo to see how effective it is in helping people with this condition.

What is already known about the treatment

Tulisokibart – Tulisokibart is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active Crohn's Disease. It is not yet approved for general medical use, as it is still under investigation to determine its safety and efficacy. The main therapeutic indication for tulisokibart is to help patients achieve clinical remission, which means reducing the symptoms of Crohn's Disease such as abdominal pain and frequent bowel movements. At the molecular level, tulisokibart works by targeting specific pathways in the immune system to reduce inflammation in the gut. It is classified pharmacologically as an immunomodulator, which means it helps to regulate the immune system's activity.

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 occur in any part of the digestive tract, leading to symptoms such as abdominal pain, diarrhea, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, causing complications like strictures and fistulas. The disease often progresses with periods of remission and flare-ups, where symptoms can become more severe. Over time, the inflammation can lead to scarring and narrowing of the intestines, affecting nutrient absorption. The exact cause of Crohn's Disease is unknown, but it involves an abnormal immune response to intestinal bacteria.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508636-61-00Protocol codeMK-7240-008Estimated enrolment1 205 patientsSponsorMerck Sharp & Dohme LLC

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