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

NCT06651281 · tracked via the Priya Life Science USA tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2024-11-25

Last updated

2026-09-09

Condition(s) studied

Crohn DiseaseColitis, Ulcerative

Investigational drug(s) / intervention(s)

Tulisokibart →Placebo to tulisokibart

Tulisokibart: Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously

Placebo to tulisokibart: Placebo matching SC tulisokibart

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 378 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 364 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Trial sites (37)

Facility	City	Region	Status
Connecticut Clinical Research Institute ( Site 0297)	Bristol	Connecticut	Recruiting
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)	Ypsilanti	Michigan	Recruiting
BVL Research - Kansas ( Site 0292)	Liberty	Missouri	Recruiting
New York Gastroenterology Associates ( Site 0253)	New York	New York	Recruiting
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)	Garland	Texas	Recruiting
GI Alliance - Lubbock ( Site 0288)	Lubbock	Texas	Recruiting
Caprock Gastro Research ( Site 0293)	Lubbock	Texas	Recruiting
Southern Star Research Institute ( Site 0299)	San Antonio	Texas	Recruiting
GI Alliance - Southlake ( Site 0298)	Southlake	Texas	Recruiting
Tyler Research Institute ( Site 0294)	Tyler	Texas	Recruiting
University of Virginia Health System ( Site 0291)	Charlottesville	Virginia	Recruiting
Washington Gastroenterology - Tacoma ( Site 0295)	Tacoma	Washington	Recruiting
Vojenská Nemocnice Brno-Internal department ( Site 0701)	Brno	Brno-mesto	Recruiting
Hepato-Gastroenterologie HK ( Site 0700)	Hradec Králové	Czechia	Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)	Nice	Alpes-Maritimes	Recruiting
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)	Neuilly-sur-Seine	Hauts-de-Seine	Recruiting
CHRU De Nancy - Hopital de Brabois ( Site 1001)	Vandœuvre-lès-Nancy	Meurthe-et-Moselle	Recruiting
Hopital Claude Huriez CHRU LILLE ( Site 1004)	Lille	Nord	Recruiting
ARENSIA Exploratory Medicine Georgia ( Site 1104)	Tbilisi	Georgia	Recruiting
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)	Békéscsaba	Bekes County	Recruiting
Semmelweis Egyetem ( Site 1400)	Budapest	Hungary	Recruiting
Rivermed Sp. z.o.o. ( Site 2206)	Poznan	Greater Poland Voivodeship	Recruiting
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)	Włocławek	Kuyavian-Pomeranian Voivodeship	Recruiting
Krakowskie Centrum Medyczne ( Site 2210)	Krakow	Lesser Poland Voivodeship	Recruiting
Centrum Medyczne Oporow ( Site 2212)	Wroclaw	Lower Silesian Voivodeship	Recruiting
Melita Medical Sp. z o.o. ( Site 2204)	Wroclaw	Lower Silesian Voivodeship	Active Not Recruiting
Przychodnia Futuremeds Wroclaw ( Site 2211)	Wroclaw	Lower Silesian Voivodeship	Active Not Recruiting
1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)	Lublin	Lublin Voivodeship	Recruiting
Medrise Sp. z o.o. ( Site 2200)	Lublin	Lublin Voivodeship	Recruiting
EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)	Warsaw	Masovian Voivodeship	Recruiting
Vivamed Sp. z o.o. ( Site 2201)	Warsaw	Masovian Voivodeship	Recruiting
WIP Warsaw IBD Point Professor Kierkus ( Site 2209)	Warsaw	Masovian Voivodeship	Recruiting
Vita Longa Sp. Zoo ( Site 2213)	Katowice	Silesian Voivodeship	Recruiting
Sonomed Sp. z o. o. ( Site 2203)	Szczecin	West Pomeranian Voivodeship	Recruiting
Bonifraterskie Centrum Medyczne ( Site 2207)	Lodz	Łódź Voivodeship	Recruiting
Whipps Cross University Hospital ( Site 3400)	London	England	Active Not Recruiting
MAC Research - Merseyside ( Site 3401)	Prescot	Knowsley	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06651281 on ClinicalTrials.gov ↗ ← All trials in the USA