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Taking people in BelgiumPhase 3

Tests tulisokibart in adults with moderately to severely active Crohn's disease

Tests tulisokibart against placebo in adults with active Crohn's disease.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Gent, Leuven, and Roeselare, BelgiumSee the 3 sitesAlso in 20 other countries, 152 sites
Trial code
Registry title
A clinical study of MK-7240 for the treatment of Crohn’s disease (MK-7240-008)
Status
Recruiting
Phase
Phase 3
People taking part
567 people, planned
Started
29 Sept 2025
Expected to end
28 Feb 2033
Type of study
Interventional
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults, and some adolescents, with moderately to severely active Crohn's disease who did not do well on earlier treatment.

Age
18 years or older. Adolescents aged 16 to under 18 can join only if the country or health authority approves.
Sex
All sexes can join.
Disease stage
Crohn's disease diagnosed at least 3 months before the study, and moderately to severely active.
Earlier treatment
Earlier treatment with one or more drug types (oral locally acting steroids, systemic steroids, immunomodulators, biologic or small molecule advanced therapies) did not work well enough, stopped working, or was not tolerated. Earlier exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody is not allowed.

Main reasons for not taking part

  • Ulcerative colitis or indeterminate colitis
  • Hepatitis B, hepatitis C or HIV infection, or active tuberculosis
  • History of cancer, unless disease free for at least 5 years (some fully treated skin or cervical cancers excepted)
  • Complications of Crohn's disease such as abscess, fulminant colitis, toxic megacolon or a stoma
  • Bowel surgery within 3 months of the study

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab)
  • 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 surgical bowel resection within 3 months of study
  • Has prior or current gastrointestinal dysplasia
  • 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
  • Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD
  • 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
  • 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
  • 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

Where in Belgium

Also in 20 other countries, 152 sites

  • Universitair Ziekenhuis GentGent, BelgiumTaking people
  • UZ LeuvenLeuven, BelgiumTaking people
  • Algemeen Ziekenhuis DeltaRoeselare, BelgiumTaking people

About the trial

What the trial wants to find out

1.Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score (<150) at Week 12 2.Study 2: EU/EMA: Evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12 3.Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
Plain-language title
Tests tulisokibart in adults with moderately to severely active Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 11 November 2026.
Record updated
10 November 2026