NCT06651281RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1380 (estimated)
- First submitted
- 18 Oct 2024
- Start date
- 25 Nov 2024
- Primary completion date
- 17 Dec 2037
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06651281
- EU CT number
- 2024-513533-20-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1380
- From 25 Nov 2024 to the primary completion date, 17 Dec 2037
- 37 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received any protocol-specified prohibited medications during their parent study
Other illness
- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Other
- Has prematurely discontinued study intervention in their parent study
Who the study is looking for
- Has participated in a qualifying tulisokibart Phase 2 or Phase 3 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann Coordinator of this site? Confirm its status | Neuilly-Sur-Seine | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Recruiting |
| Whipps Cross University Hospital ( Site 3400) Coordinator of this site? Confirm its status | London | United Kingdom | Active, not recruiting |
| MAC Research - Merseyside ( Site 3401) Coordinator of this site? Confirm its status | Prescot | United Kingdom | Recruiting |
| ARENSIA Exploratory Medicine Georgia ( Site 1104) Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Bekescsaba | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Vita Longa Sp. Z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Bonifraterskie Centrum Medyczne sp. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Rivermed Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Sonomed Sp. z o.o. Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Eb Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Coordinator of this site? Confirm its status | Warszawa | Poland | Recruiting |
| Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Coordinator of this site? Confirm its status | Wloclawek | Poland | Recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Melita Medical Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Connecticut Clinical Research Institute ( Site 0297) Coordinator of this site? Confirm its status | Bristol | United States | Recruiting |
| University of Virginia Health System ( Site 0291) Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290) Coordinator of this site? Confirm its status | Garland | United States | Recruiting |
| BVL Research - Kansas ( Site 0292) Coordinator of this site? Confirm its status | Liberty | United States | Recruiting |
| Caprock Gastro Research ( Site 0293) Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| GI Alliance - Lubbock ( Site 0288) Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| New York Gastroenterology Associates ( Site 0253) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Southern Star Research Institute ( Site 0299) Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| GI Alliance - Southlake ( Site 0298) Coordinator of this site? Confirm its status | Southlake | United States | Recruiting |
| Washington Gastroenterology - Tacoma ( Site 0295) Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Tyler Research Institute ( Site 0294) Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.