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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease, Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT06651281

Run by

Merck Sharp & Dohme LLC

People needed

1380

Starts

2024-11-25

Expected to finish

2037-12-17

Last updated by the study team

2026-05-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• MAC Research - Merseyside ( Site 3401) — Prescot, Knowsley, United Kingdom (enrolling)
• St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) — Ypsilanti, Michigan, United States (enrolling)
• BVL Research - Kansas ( Site 0292) — Liberty, Missouri, United States (enrolling)
• New York Gastroenterology Associates ( Site 0253) — New York, New York, United States (enrolling)
• GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290) — Garland, Texas, United States (enrolling)
• GI Alliance - Lubbock ( Site 0288) — Lubbock, Texas, United States (enrolling)
• Caprock Gastro Research ( Site 0293) — Lubbock, Texas, United States (enrolling)
• Southern Star Research Institute ( Site 0299) — San Antonio, Texas, United States (enrolling)
• GI Alliance - Southlake ( Site 0298) — Southlake, Texas, United States (enrolling)
• Tyler Research Institute ( Site 0294) — Tyler, Texas, United States (enrolling)
• University of Virginia Health System ( Site 0291) — Charlottesville, Virginia, United States (enrolling)
• Washington Gastroenterology - Tacoma ( Site 0295) — Tacoma, Washington, United States (enrolling)
• Vojenská Nemocnice Brno-Internal department ( Site 0701) — Brno, Brno-mesto, Czechia (enrolling)
• Hepato-Gastroenterologie HK ( Site 0700) — Hradec Králové, Czechia (enrolling)
• Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002) — Nice, Alpes-Maritimes, France (enrolling)
• CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003) — Neuilly-sur-Seine, Hauts-de-Seine, France (enrolling)
• CHRU De Nancy - Hopital de Brabois ( Site 1001) — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France (enrolling)
• Hopital Claude Huriez CHRU LILLE ( Site 1004) — Lille, Nord, France (enrolling)
• ARENSIA Exploratory Medicine Georgia ( Site 1104) — Tbilisi, Georgia (enrolling)
• Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411) — Békéscsaba, Bekes County, Hungary (enrolling)
• Semmelweis Egyetem ( Site 1400) — Budapest, Hungary (enrolling)
• Rivermed Sp. z.o.o. ( Site 2206) — Poznan, Greater Poland Voivodeship, Poland (enrolling)
• Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208) — Włocławek, Kuyavian-Pomeranian Voivodeship, Poland (enrolling)
• Krakowskie Centrum Medyczne ( Site 2210) — Krakow, Lesser Poland Voivodeship, Poland (enrolling)
• Centrum Medyczne Oporow ( Site 2212) — Wroclaw, Lower Silesian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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