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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
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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
CHRU De Nancy
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Vandoeuvre Les NancyFranceRecruiting
Whipps Cross University Hospital ( Site 3400)
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LondonUnited KingdomActive, not recruiting
MAC Research - Merseyside ( Site 3401)
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PrescotUnited KingdomRecruiting
ARENSIA Exploratory Medicine Georgia ( Site 1104)
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TbilisiGeorgiaRecruiting
Bekes Varmegyei Koezponti Korhaz
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BekescsabaHungaryRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Futuremeds Sp. z o.o.
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CracowPolandRecruiting
Vita Longa Sp. Z o.o.
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KatowicePolandRecruiting
Bonifraterskie Centrum Medyczne sp. z o.o
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LodzPolandRecruiting
Medrise Sp. z o.o.
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LublinPolandRecruiting
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
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LublinPolandRecruiting
Rivermed Sp. z o.o.
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PoznanPolandRecruiting
Sonomed Sp. z o.o.
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SzczecinPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Eb Group Sp. z o.o.
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WarsawPolandRecruiting
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
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WarszawaPolandRecruiting
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
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WloclawekPolandRecruiting
Futuremeds Sp. z o.o.
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WroclawPolandRecruiting
Centrum Medyczne Oporow
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WroclawPolandRecruiting
Melita Medical Sp. z o.o.
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WroclawPolandRecruiting
Connecticut Clinical Research Institute ( Site 0297)
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BristolUnited StatesRecruiting
University of Virginia Health System ( Site 0291)
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CharlottesvilleUnited StatesRecruiting
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
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GarlandUnited StatesRecruiting
BVL Research - Kansas ( Site 0292)
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LibertyUnited StatesRecruiting
Caprock Gastro Research ( Site 0293)
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LubbockUnited StatesRecruiting
GI Alliance - Lubbock ( Site 0288)
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LubbockUnited StatesRecruiting
New York Gastroenterology Associates ( Site 0253)
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New YorkUnited StatesRecruiting
Southern Star Research Institute ( Site 0299)
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San AntonioUnited StatesRecruiting
GI Alliance - Southlake ( Site 0298)
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SouthlakeUnited StatesRecruiting
Washington Gastroenterology - Tacoma ( Site 0295)
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TacomaUnited StatesRecruiting
Tyler Research Institute ( Site 0294)
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TylerUnited StatesRecruiting
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
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YpsilantiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.