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Taking people in CzechiaPhase 3

Long-term safety study of tulisokibart in Crohn's disease or ulcerative colitis

Studies long-term safety of tulisokibart in adults with Crohn's disease or colitis.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
Brno-Zidenice and Hradec Králové, CzechiaSee the 2 sitesAlso in 6 other countries, 35 sites
Trial code
Registry title
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Status
Recruiting
Phase
Phase 3
People taking part
1,380 people, planned
Started
25 Nov 2024
Expected to end
17 Dec 2037
Type of study
Interventional, 4 groups
Treatments tested
  • Tulisokibart
  • Placebo to tulisokibart
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 with Crohn's disease or ulcerative colitis who took part in a tulisokibart parent study and whose investigator sees clinical benefit from continuing.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Crohn's disease or ulcerative colitis; the trial takes people who finished a tulisokibart parent study for these diseases.
Earlier treatment
Must have taken part in a qualifying tulisokibart parent study for Crohn's disease or ulcerative colitis.

Main reasons for not taking part

  • Stopped the study treatment early in the parent study
  • Took medicines that the protocol does not allow during the parent study
  • Known allergy, hypersensitivity or intolerance to tulisokibart or its other ingredients
  • Breastfeeding during the study treatment and for at least 14 weeks after the last dose
  • Pregnant, or a positive pregnancy test before the first dose

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Has participated in a qualifying tulisokibart parent study for CD or UC
  • The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
  • A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
  • A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
  • A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Who cannot take part

  • Has received any protocol-specified prohibited medications during their parent study
  • Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
  • Has prematurely discontinued study intervention in their parent study

Where in Czechia

Also in 6 other countries, 35 sites

  • Vojenska Nemocnice BrnoBrno-Zidenice, CzechiaTaking people
  • Hepato-Gastroenterologie HK, s.r.o.Hradec Králové, CzechiaTaking people

About the trial

What the trial wants to find out

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

The 4 groups in the trial

  • Group 1: Low Dose UnblindedTreatment being tested

    Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

    Treatment: Tulisokibart

  • Group 2: High Dose UnblindedTreatment being tested

    Participants receive a high dose SC tulisokibart regimen.

    Treatment: Tulisokibart

  • Group 3: High Dose BlindedTreatment being tested

    Participants receive a blinded high dose SC tulisokibart regimen.

    Treatment: Tulisokibart

  • Group 4: Low Dose BlindedTreatment being tested

    Participants receive a blinded low dose SC tulisokibart regimen.

    Treatment: Tulisokibart and Placebo to tulisokibart

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 → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
Plain-language title
Long-term safety study of tulisokibart in Crohn's disease or ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 November 2026