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Looking for participantsPhase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06430801

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
IV Tulisokibart (drug), SC Tulisokibart (drug), IV Placebo (other), SC Placebo (other)
How long the study runs
Study runs about 65 months (dates as stated)
About the drug or intervention
IV Tulisokibart — drug: Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously · SC Tulisokibart — drug: Humanized monoclonal antibody that binds human TL1A, administered subcutaneously · IV Placebo — other: Placebo matching IV tulisokibart · SC Placebo — other: Placebo matching SC tulisokibart
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
16 Years to 80 Years
Who
All
Number of participants
1,200
Started
2024-06-05
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for crohn's disease
  • • Phase3 - 1,200 participants
  • • The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease

Who can take part?

  • • Ages 16 Years to 80 Years
  • • Diagnosed with crohn's disease

Where?

  • • Cambridge - Addenbrooke's Hospital ( Site 2400)
  • • Exeter - Royal Devon & Exeter Hospital ... ( Site 2407)
  • • Doncaster - Doncaster Royal Infirmary ( Site 2401)
  • • Huddersfield - Huddersfield Royal Infirmary ( Site 2409)
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

More detail

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Crohn's Disease

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
  • ✓Has moderately to severely active CD.
  • ✓Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health...

Who cannot take part

  • ✗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...
  • ✗Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
See the full criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 Criteria: * 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).

Where Is This Study? (10 UK sites)

Addenbrooke's Hospital ( Site 2400)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441223331130

Royal Devon & Exeter Hospital ... ( Site 2407)

Exeter EX2 5DW, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Doncaster Royal Infirmary ( Site 2401)

Doncaster DN2 5LT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01302643331

Huddersfield Royal Infirmary ( Site 2409)

Huddersfield HD3 3EA, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01484342905

Whipps Cross University Hospital-Clinical Research Unit ( Site 2404)

London E11 1NR, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 8539 5522

Southampton General Hospital ( Site 2402)

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator023 8077 7222

University College London Hospital-Clinical Research Facility ( Site 2405)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442034477618

The John Radcliffe Hospital ( Site 2406)

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01865 231618

Southmead Hospital ( Site 2403)

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0117 414 8133

Walsall Manor Hospital ( Site 2410)

West Midlands WS2 9PS, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10