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.
Plain-language title generated from the registry record
Registry title: Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Key facts
- Where
- Lille Cedex, Neuilly-Sur-Seine, Nice, and Vandoeuvre Les Nancy, FranceSee the 4 sites
- Phase
- Phase 3
Where in France
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-Seine, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06651281EU 2024-513533-20-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
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.
Inclusion: 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).
Exclusion: 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.