RECRUITING Phase 3 ClinicalTrials.gov

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06651281

Registry updated: 2026-10-02

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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.

Interventions

Tulisokibart (Drug)
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Placebo to tulisokibart (Drug)
Placebo matching SC tulisokibart

Eligibility criteria

Inclusion Criteria: * 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) Exclusion Criteria: * Has prematurely discontinued study intervention in their parent study * Has received any protocol-specified prohibited medications during their parent study * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Conditions

Crohn Disease Colitis, Ulcerative

Locations

Connecticut Clinical Research Institute ( Site 0297) — Bristol, Connecticut, United States
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) — Ypsilanti, Michigan, United States
BVL Research - Kansas ( Site 0292) — Liberty, Missouri, United States
New York Gastroenterology Associates ( Site 0253) — New York, New York, United States
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290) — Garland, Texas, United States
GI Alliance - Lubbock ( Site 0288) — Lubbock, Texas, United States
Caprock Gastro Research ( Site 0293) — Lubbock, Texas, United States
Southern Star Research Institute ( Site 0299) — San Antonio, Texas, United States
GI Alliance - Southlake ( Site 0298) — Southlake, Texas, United States
Tyler Research Institute ( Site 0294) — Tyler, Texas, United States
University of Virginia Health System ( Site 0291) — Charlottesville, Virginia, United States
Washington Gastroenterology - Tacoma ( Site 0295) — Tacoma, Washington, United States
Vojenská Nemocnice Brno-Internal department ( Site 0701) — Brno, Brno-mesto, Czechia
Hepato-Gastroenterologie HK ( Site 0700) — Hradec Králové, Czechia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002) — Nice, Alpes-Maritimes, France
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003) — Neuilly-sur-Seine, Hauts-de-Seine, France
CHRU De Nancy - Hopital de Brabois ( Site 1001) — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Hopital Claude Huriez CHRU LILLE ( Site 1004) — Lille, Nord, France
ARENSIA Exploratory Medicine Georgia ( Site 1104) — Tbilisi, Georgia
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411) — Békéscsaba, Bekes County, Hungary
Semmelweis Egyetem ( Site 1400) — Budapest, Hungary
Rivermed Sp. z.o.o. ( Site 2206) — Poznan, Greater Poland Voivodeship, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208) — Włocławek, Kuyavian-Pomeranian Voivodeship, Poland
Krakowskie Centrum Medyczne ( Site 2210) — Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Oporow ( Site 2212) — Wroclaw, Lower Silesian Voivodeship, Poland
Melita Medical Sp. z o.o. ( Site 2204) — Wroclaw, Lower Silesian Voivodeship, Poland
Przychodnia Futuremeds Wroclaw ( Site 2211) — Wroclaw, Lower Silesian Voivodeship, Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205) — Lublin, Lublin Voivodeship, Poland
Medrise Sp. z o.o. ( Site 2200) — Lublin, Lublin Voivodeship, Poland
EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202) — Warsaw, Masovian Voivodeship, Poland
Vivamed Sp. z o.o. ( Site 2201) — Warsaw, Masovian Voivodeship, Poland
WIP Warsaw IBD Point Professor Kierkus ( Site 2209) — Warsaw, Masovian Voivodeship, Poland
Vita Longa Sp. Zoo ( Site 2213) — Katowice, Silesian Voivodeship, Poland
Sonomed Sp. z o. o. ( Site 2203) — Szczecin, West Pomeranian Voivodeship, Poland
Bonifraterskie Centrum Medyczne ( Site 2207) — Lodz, Łódź Voivodeship, Poland
MAC Research - Merseyside ( Site 3401) — Prescot, Knowsley, United Kingdom
Whipps Cross University Hospital ( Site 3400) — London, Waltham Forest, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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