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A Study of Tulisokibart for Moderate to Severe Crohn's Disease

This study is testing a new medication called tulisokibart (MK-7240) for people with moderate to severe Crohn's disease. Tulisokibart is a humanized monoclonal antibody that targets a specific protein called TL1A. Researchers want to see how well tulisokibart works and if it's safe when given either through an IV (intravenously) or as a shot under the skin (subcutaneously). Some participants will receive a placebo (an inactive substance) instead of the study drug. You may be able to join if you are between 16 and 80 years old, have had Crohn's disease for at least 3 months, and your current treatments haven't worked well enough. The study will measure success by looking at how many participants achieve clinical remission (a significant reduction in symptoms) and endoscopic response (healing of the bowel lining) after 52 weeks.

Study design
This is an interventional study planning to enroll 1200 participants. It compares different forms of tulisokibart to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 52 weeks to assess the study's outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06430801

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Merck Sharp & Dohme LLC
~1,200 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:IV TulisokibartSC TulisokibartIV PlaceboSC Placebo

At a glance

Recruiting sites
457 of 499 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
Measured over Week 52
+8 more outcomes measured

Conditions

Crohn's Disease

Explore related trials

Crohn Disease

Where it's being run

499 sites across 252 states
Japan15
Texas11
Florida10
California9
Israel9
Tokyo8
Turkey (Türkiye)8
Ontario7

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
Has moderately to severely active CD.
Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion

Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Has current stoma or need for colostomy or ileostomy.
Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
Has surgical bowel resection within 3 months of study.
Has prior or current gastrointestinal dysplasia.
Has chronic infection requiring ongoing antimicrobial treatment.
Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.
Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Has active tuberculosis.
Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

What this trial measures

  • Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  • Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52Week 52

    The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

  • Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52Week 52

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for Study 1 will be presented.

  • Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  • Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

  • Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 1 will be presented.

  • Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 2 will be presented.

  • Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

  • Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 2 will be presented.