RecruitingPhase 3NCT06651281

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,380 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This is an extension study for patients who already completed a Phase 2 or Phase 3 trial of tulisokibart — a biologic medication being studied for Crohn's disease (CD) or ulcerative colitis (UC). Participants who benefited from the drug in the parent study can continue receiving it here to assess long-term safety and effectiveness. **You may be eligible if...** - You already participated in a qualifying tulisokibart parent study - Your doctor believes you are continuing to benefit from the drug - You are not pregnant and agree to contraception requirements - You have a negative pregnancy test if required **You may NOT be eligible if...** - You did not participate in a qualifying tulisokibart parent study - You are breastfeeding during treatment or within 14 weeks after the last dose - You are pregnant or have a positive pregnancy test at enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTulisokibart

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

DRUGPlacebo to tulisokibart

Placebo matching SC tulisokibart


Locations(37)

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 ( 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

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

Whipps Cross University Hospital ( Site 3400)

London, England, United Kingdom

MAC Research - Merseyside ( Site 3401)

Prescot, Knowsley, United Kingdom

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NCT06651281


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