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NCT06651281PHASE3Recruiting

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

Merck Sharp & Dohme LLC

Start Date

11/25/2024

Completion Date

12/17/2037

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 Criteria

Age Range: No minimum to No maximum

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

Interventions

DRUG

Tulisokibart

DRUG

Placebo to tulisokibart

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Conditions

Crohn DiseaseColitis, Ulcerative

Locations

Connecticut Clinical Research Institute ( Site 0297)

Bristol, Connecticut 06010

United States

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

Ypsilanti, Michigan 48197

United States

BVL Research - Kansas ( Site 0292)

Liberty, Missouri 64068

United States

New York Gastroenterology Associates ( Site 0253)

New York, New York 10075

United States

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

Garland, Texas 75044

United States

GI Alliance - Lubbock ( Site 0288)

Lubbock, Texas 79410

United States

Caprock Gastro Research ( Site 0293)

Lubbock, Texas 79424

United States

Southern Star Research Institute ( Site 0299)

San Antonio, Texas 78229

United States

GI Alliance - Southlake ( Site 0298)

Southlake, Texas 76092-9167

United States

Tyler Research Institute ( Site 0294)

Tyler, Texas 75701

United States

University of Virginia Health System ( Site 0291)

Charlottesville, Virginia 22908

United States

Washington Gastroenterology - Tacoma ( Site 0295)

Tacoma, Washington 98405

United States

Vojenská Nemocnice Brno-Internal department ( Site 0701)

Brno, Brno-mesto 615 00

Czechia

Hepato-Gastroenterologie HK ( Site 0700)

Hradec Králové, 50012

Czechia

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

Nice, Alpes-Maritimes 06202

France

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

Neuilly-sur-Seine, Hauts-de-Seine 92200

France

CHRU De Nancy - Hopital de Brabois ( Site 1001)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54500

France

Hopital Claude Huriez CHRU LILLE ( Site 1004)

Lille, Nord 59037

France

ARENSIA Exploratory Medicine Georgia ( Site 1104)

Tbilisi, 0112

Georgia

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

Békéscsaba, Bekes County 5600

Hungary

Semmelweis Egyetem ( Site 1400)

Budapest, 1082

Hungary

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

Poznan, Greater Poland Voivodeship 61-441

Poland

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

Włocławek, Kuyavian-Pomeranian Voivodeship 87-800

Poland

Krakowskie Centrum Medyczne ( Site 2210)

Krakow, Lesser Poland Voivodeship 31-501

Poland

Centrum Medyczne Oporow ( Site 2212)

Wroclaw, Lower Silesian Voivodeship 52-416

Poland

Melita Medical Sp. z o.o. ( Site 2204)

Wroclaw, Lower Silesian Voivodeship 53-611

Poland

Przychodnia Futuremeds Wroclaw ( Site 2211)

Wroclaw, Lower Silesian Voivodeship 53-673

Poland

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

Lublin, Lublin Voivodeship 20-059

Poland

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

Lublin, Lublin Voivodeship 20-582

Poland

EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)

Warsaw, Masovian Voivodeship 00-189

Poland

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

Warsaw, Masovian Voivodeship 03-580

Poland

WIP Warsaw IBD Point Professor Kierkus ( Site 2209)

Warsaw, Masovian Voivodeship 04-501

Poland

Vita Longa Sp. Zoo ( Site 2213)

Katowice, Silesian Voivodeship 40-748

Poland

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

Szczecin, West Pomeranian Voivodeship 71-685

Poland

Bonifraterskie Centrum Medyczne ( Site 2207)

Lodz, Łódź Voivodeship 93-357

Poland

Whipps Cross University Hospital ( Site 3400)

London, England E11 1NR

United Kingdom

MAC Research - Merseyside ( Site 3401)

Prescot, Knowsley L34 1BH

United Kingdom