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

NCT ID: NCT06651281

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2037-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease Colitis, Ulcerative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This extension study will enroll participants who choose to enter from certain studies in which they are already receiving treatment (their "parent studies"). They will enter the appropriate arm in this study that will provide the same treatment they had been receiving on their parent study.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants in "Group 1: Low Dose Unblinded" and "Group 2: High Dose Unblinded" received open-label treatment on their parent studies, and will remain unblinded on this extension study.

Participants in "Group 3: High Dose Blinded" and "Group 4: Low Dose Blinded" were all blinded on their parent studies, and will remain blinded on this extension study until after regulatory approval or market authorization in the United States or European Medicines Agency, per sponsor discretion.

Study Groups

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Group 1: Low Dose Unblinded

Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

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

Group 2: High Dose Unblinded

Participants receive a high dose SC tulisokibart regimen.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

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

Group 3: High Dose Blinded

Participants receive a blinded high dose SC tulisokibart regimen.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

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

Group 4: Low Dose Blinded

Participants receive a blinded low dose SC tulisokibart regimen.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

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

Placebo to tulisokibart

Intervention Type DRUG

Placebo matching SC tulisokibart

Interventions

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Tulisokibart

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

Intervention Type DRUG

Placebo to tulisokibart

Placebo matching SC tulisokibart

Intervention Type DRUG

Other Intervention Names

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MK-7240

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Connecticut Clinical Research Institute ( Site 0297)

Bristol, Connecticut, United States

Site Status RECRUITING

St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)

Ypsilanti, Michigan, United States

Site Status RECRUITING

BVL Research - Kansas ( Site 0292)

Liberty, Missouri, United States

Site Status RECRUITING

New York Gastroenterology Associates ( Site 0253)

New York, New York, United States

Site Status RECRUITING

GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)

Garland, Texas, United States

Site Status RECRUITING

GI Alliance - Lubbock ( Site 0288)

Lubbock, Texas, United States

Site Status RECRUITING

Caprock Gastro Research ( Site 0293)

Lubbock, Texas, United States

Site Status RECRUITING

Southern Star Research Institute ( Site 0299)

San Antonio, Texas, United States

Site Status RECRUITING

GI Alliance - Southlake ( Site 0298)

Southlake, Texas, United States

Site Status RECRUITING

Tyler Research Institute ( Site 0294)

Tyler, Texas, United States

Site Status RECRUITING

University of Virginia Health System ( Site 0291)

Charlottesville, Virginia, United States

Site Status RECRUITING

Washington Gastroenterology - Tacoma ( Site 0295)

Tacoma, Washington, United States

Site Status RECRUITING

Vojenská Nemocnice Brno-Internal department ( Site 0701)

Brno, Brno-mesto, Czechia

Site Status RECRUITING

Hepato-Gastroenterologie HK ( Site 0700)

Hradec Králové, , Czechia

Site Status RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)

Nice, Alpes-Maritimes, France

Site Status RECRUITING

CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)

Neuilly-sur-Seine, Hauts-de-Seine, France

Site Status RECRUITING

CHRU De Nancy - Hopital de Brabois ( Site 1001)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Site Status RECRUITING

Hopital Claude Huriez CHRU LILLE ( Site 1004)

Lille, Nord, France

Site Status RECRUITING

ARENSIA Exploratory Medicine Georgia ( Site 1104)

Tbilisi, , Georgia

Site Status RECRUITING

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)

Békéscsaba, Bekes County, Hungary

Site Status RECRUITING

Semmelweis Egyetem ( Site 1400)

Budapest, , Hungary

Site Status RECRUITING

Rivermed Sp. z.o.o. ( Site 2206)

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Krakowskie Centrum Medyczne ( Site 2210)

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Centrum Medyczne Oporow ( Site 2212)

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Melita Medical ( Site 2204)

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Przychodnia Futuremeds Wroclaw ( Site 2211)

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

Medrise Sp. z o.o. ( Site 2200)

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

Centrum Zdrowia MDM ( Site 2202)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Vivamed Sp. z o.o. ( Site 2201)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

WIP Warsaw IBD Point Professor Kierkus ( Site 2209)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Vita Longa Sp. Zoo ( Site 2213)

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Sonomed Sp. z o. o. ( Site 2203)

Szczecin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

Bonifraterskie Centrum Medyczne ( Site 2207)

Lodz, Łódź Voivodeship, Poland

Site Status RECRUITING

Whipps Cross University Hospital ( Site 3400)

London, England, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

MAC Research - Merseyside ( Site 3401)

Prescot, Knowsley, United Kingdom

Site Status RECRUITING

Countries

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Australia United States Czechia France Georgia Hungary Poland United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26142&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

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2024-513533-20-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1306-6970

Identifier Type: REGISTRY

Identifier Source: secondary_id

7240-011

Identifier Type: -

Identifier Source: org_study_id