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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)
NCT06651281 · Merck Sharp & Dohme LLC
In plain English
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Official title
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
About this study
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
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
Study design
Enrollment target: 1380 participants
Allocation: non_randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2024-11-25
Estimated completion: 2037-12-17
Last updated: 2025-12-26
Interventions
Drug: TulisokibartDrug: Placebo to tulisokibart
Primary outcomes
- • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 378 weeks)
- • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 364 weeks)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (37)
Connecticut Clinical Research Institute ( Site 0297)Recruiting
Bristol, Connecticut, United States
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)Recruiting
Ypsilanti, Michigan, United States
BVL Research - Kansas ( Site 0292)Recruiting
Liberty, Missouri, United States
New York Gastroenterology Associates ( Site 0253)Recruiting
New York, New York, United States
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)Recruiting
Garland, Texas, United States
GI Alliance - Lubbock ( Site 0288)Recruiting
Lubbock, Texas, United States
Caprock Gastro Research ( Site 0293)Recruiting
Lubbock, Texas, United States
Southern Star Research Institute ( Site 0299)Recruiting
San Antonio, Texas, United States
GI Alliance - Southlake ( Site 0298)Recruiting
Southlake, Texas, United States
Tyler Research Institute ( Site 0294)Recruiting
Tyler, Texas, United States
University of Virginia Health System ( Site 0291)Recruiting
Charlottesville, Virginia, United States
Washington Gastroenterology - Tacoma ( Site 0295)Recruiting
Tacoma, Washington, United States
Vojenská Nemocnice Brno-Internal department ( Site 0701)Recruiting
Brno, Brno-mesto, Czechia
Hepato-Gastroenterologie HK ( Site 0700)Recruiting
Hradec Králové, Czechia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)Recruiting
Nice, Alpes-Maritimes, France
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)Recruiting
Neuilly-sur-Seine, Hauts-de-Seine, France
CHRU De Nancy - Hopital de Brabois ( Site 1001)Recruiting
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Hopital Claude Huriez CHRU LILLE ( Site 1004)Recruiting
Lille, Nord, France
ARENSIA Exploratory Medicine Georgia ( Site 1104)Recruiting
Tbilisi, Georgia
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)Recruiting
Békéscsaba, Bekes County, Hungary
Semmelweis Egyetem ( Site 1400)Recruiting
Budapest, Hungary
Rivermed Sp. z.o.o. ( Site 2206)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)Recruiting
Włocławek, Kuyavian-Pomeranian Voivodeship, Poland
Krakowskie Centrum Medyczne ( Site 2210)Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Oporow ( Site 2212)Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Melita Medical ( Site 2204)Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Przychodnia Futuremeds Wroclaw ( Site 2211)Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)Recruiting
Lublin, Lublin Voivodeship, Poland
Medrise Sp. z o.o. ( Site 2200)Recruiting
Lublin, Lublin Voivodeship, Poland
Centrum Zdrowia MDM ( Site 2202)Recruiting
Warsaw, Masovian Voivodeship, Poland
Vivamed Sp. z o.o. ( Site 2201)Recruiting
Warsaw, Masovian Voivodeship, Poland
WIP Warsaw IBD Point Professor Kierkus ( Site 2209)Recruiting
Warsaw, Masovian Voivodeship, Poland
Vita Longa Sp. Zoo ( Site 2213)Recruiting
Katowice, Silesian Voivodeship, Poland
Sonomed Sp. z o. o. ( Site 2203)Recruiting
Szczecin, West Pomeranian Voivodeship, Poland
Bonifraterskie Centrum Medyczne ( Site 2207)Recruiting
Lodz, Łódź Voivodeship, Poland
Whipps Cross University Hospital ( Site 3400)Active Not Recruiting
London, England, United Kingdom
MAC Research - Merseyside ( Site 3401)Recruiting
Prescot, Knowsley, United Kingdom