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Study of tulisokibart compared to placebo in adults with moderate to severe 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 studies the effectiveness and safety of tulisokibart (also known as MK-7240) in people who have Crohn's Disease. Crohn's Disease is a long-lasting condition that causes inflammation in the digestive tract, leading to symptoms such as stomach pain and diarrhea. The condition can range from moderate to severe, affecting daily life and overall well-being.

The study will test tulisokibart against placebo to see if it can help patients achieve remission, which means a significant reduction in disease symptoms. The medication will be given in two different ways: through intravenous infusion (delivered directly into a vein) or through subcutaneous injection (given under the skin using a pre-filled injector).

During the study, participants will receive treatment for 12 weeks. The researchers will monitor various aspects of the disease, including changes in symptoms such as abdominal pain and stool frequency. They will also examine the inside of the digestive tract to check if the treatment reduces inflammation and helps heal the intestinal lining. Throughout the study, participants will have regular check-ups to monitor their health and any potential side effects.

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

    Your participation begins after being diagnosed with Crohn's Disease for at least 3 months

    The study accepts patients with moderate to severe Crohn's Disease who have not responded well to previous treatments such as steroids, immunomodulators, or other therapies

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either tulisokibart or a placebo (inactive substance)

    The treatment will be administered in one of two ways:

    - Through an intravenous infusion (medicine given through a vein)

    - Through a subcutaneous injection (injection under the skin) using a pre-filled injector

  3. Step 3

    12-week treatment period

    Your condition will be monitored for 12 weeks

    During this period, medical staff will track:

    - Changes in your stool frequency

    - Level of abdominal pain

    - Overall disease activity using the Crohn's Disease Activity Index

    - Your fatigue levels

    - Quality of life related to inflammatory bowel disease

  4. Step 4

    Endoscopic evaluations

    At week 12, you will undergo an endoscopic examination to assess:

    - Response to treatment

    - Presence of ulcers in your digestive tract

    This procedure will help determine if the treatment has improved the condition of your digestive system

  5. Step 5

    Safety monitoring

    Throughout the study, medical staff will monitor for any side effects or adverse reactions

    Your safety will be continuously evaluated

    The study is expected to continue until February 2033

Who can join the trial?

9 criteria

  • Must have been diagnosed with Crohn's Disease for at least 3 months before the study begins
  • Must have moderate to severe Crohn's Disease (meaning significant symptoms that affect daily life)
  • Must have had an inadequate response to, lost response to, or could not tolerate at least one of these previous treatments:
    • Oral locally acting steroids (medications that work mainly in the gut)
    • Systemic steroids (medications that affect the whole body)
    • Immunomodulators (medications that adjust immune system activity)
    • Biologics (protein-based medications) or small molecule therapies (newer types of medications)
    • Must be 16 years of age or older
    • Both men and women can participate in the study
    • Adolescents between 16 and 18 years old may participate if approved by their country's health authorities

Who cannot join the trial?

15 criteria

  • History of extensive bowel surgery or short bowel syndrome (a condition where part of the small intestine is missing or has been removed)
  • Active or latent (dormant) tuberculosis
  • Current serious infections including hepatitis B or hepatitis C
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe heart, lung, kidney, or liver disease
  • Current or recent use of other biological medications for Crohn's Disease
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to similar medications
  • Active intestinal infections, including C. difficile
  • Presence of intestinal strictures (narrowing of the intestine) with obstructive symptoms
  • Uncontrolled high blood pressure or diabetes
  • History of severe mental health conditions that could interfere with study participation
  • Live vaccines received within 4 weeks before study start
  • Current participation in other clinical trials
  • Drug or alcohol abuse within the past 6 months
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Investigated drugs

Tulisokibart is an investigational medication being studied for treating moderate to severe Crohn's Disease. It is being tested to see if it can help reduce symptoms like abdominal pain and frequent bowel movements, and improve the appearance of the intestinal lining when viewed through an endoscope. This medication is being compared to a placebo to determine how well it works in achieving remission (reduction of disease symptoms) in people with Crohn's Disease after 12 weeks of treatment.

What is already known about the treatment

Tulisokibart - A novel investigational biologic medication currently undergoing Phase 3 clinical trials for the treatment of moderately to severely active Crohn's Disease. This drug is being evaluated through a randomized, double-blind, placebo-controlled study to assess its efficacy in achieving clinical remission and endoscopic response in patients. While the specific administration method isn't detailed in the source data, as a biologic medication it is likely administered through subcutaneous injection or intravenous infusion. The drug is being studied for its potential to reduce symptoms such as abdominal pain and abnormal stool frequency in Crohn's Disease patients, with effectiveness being measured at 12 weeks of treatment.

Investigated diseases

Crohn's Disease - A chronic inflammatory condition that can affect any part of the digestive tract, from mouth to anus. The disease typically develops in patches, where healthy parts of the intestine are found between inflamed areas. It causes inflammation of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, and weight loss. The inflammation often spreads deep into the layers of affected bowel tissue. Crohn's Disease can develop at any age, but most people are diagnosed in their late teens or early 20s. The condition tends to fluctuate between periods of active disease and remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518296-56-00Protocol codeMK-7240-008 study 2Estimated enrolment1 200 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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