Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Recruiting · NCT06651281 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
60 locations listed across 7 US states.
- Connecticut Clinical Research Institute ( Site 0297) - Bristol, Connecticut, United States
- Connecticut Clinical Research Institute ( Site 0297) - Bristol, Connecticut, United States
- St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) - Ypsilanti, Michigan, United States
- St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) - Ypsilanti, Michigan, United States
- BVL Research - Kansas ( Site 0292) - Liberty, Missouri, United States
- BVL Research - Kansas ( Site 0292) - Liberty, Missouri, United States
- New York Gastroenterology Associates ( Site 0253) - New York, New York, 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 - 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
- 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
- Southern Star Research Institute ( Site 0299) - San Antonio, Texas, United States
- GI Alliance - Southlake ( Site 0298) - Southlake, Texas, United States
- GI Alliance - Southlake ( Site 0298) - Southlake, Texas, United States
- Tyler Research Institute ( Site 0294) - Tyler, Texas, United States
- Tyler Research Institute ( Site 0294) - Tyler, Texas, United States
- University of Virginia Health System ( Site 0291) - Charlottesville, Virginia, United States
- University of Virginia Health System ( Site 0291) - Charlottesville, Virginia, United States
- Washington Gastroenterology - Tacoma ( Site 0295) - Tacoma, Washington, United States
- Washington Gastroenterology - Tacoma ( Site 0295) - Tacoma, Washington, United States
- Semmelweis Egyetem ( Site 1400) - Budapest, Hungary
- Semmelweis Egyetem ( Site 1400) - Budapest, Hungary
- Hepato-Gastroenterologie HK ( Site 0700) - Hradec Králové, Czechia
- Hepato-Gastroenterologie HK ( Site 0700) - Hradec Králové, Czechia
- ARENSIA Exploratory Medicine Georgia ( Site 1104) - Tbilisi, Georgia
- ARENSIA Exploratory Medicine Georgia ( Site 1104) - Tbilisi, Georgia
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002) - Nice, Alpes-Maritimes, France
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002) - Nice, Alpes-Maritimes, France
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411) - Békéscsaba, Bekes County, Hungary
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411) - Békéscsaba, Bekes County, Hungary
- Vojenská Nemocnice Brno-Internal department ( Site 0701) - Brno, Brno-mesto, Czechia
- Vojenská Nemocnice Brno-Internal department ( Site 0701) - Brno, Brno-mesto, Czechia
- Whipps Cross University Hospital ( Site 3400) - London, England, United Kingdom
- Whipps Cross University Hospital ( Site 3400) - London, England, United Kingdom
- Rivermed Sp. z.o.o. ( Site 2206) - Poznan, Greater Poland Voivodeship, Poland
- Rivermed Sp. z.o.o. ( Site 2206) - Poznan, Greater Poland Voivodeship, Poland
- CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003) - Neuilly-sur-Seine, Hauts-de-Seine, France
- CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003) - Neuilly-sur-Seine, Hauts-de-Seine, France
- MAC Research - Merseyside ( Site 3401) - Prescot, Knowsley, United Kingdom
- MAC Research - Merseyside ( Site 3401) - Prescot, Knowsley, United Kingdom
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208) - Włocławek, Kuyavian-Pomeranian 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
- Krakowskie Centrum Medyczne ( Site 2210) - Krakow, Lesser Poland Voivodeship, Poland
- Centrum Medyczne Oporow ( Site 2212) - Wroclaw, Lower Silesian Voivodeship, Poland
- Melita Medical Sp. z o.o. ( Site 2204) - Wroclaw, Lower Silesian Voivodeship, Poland
- Przychodnia Futuremeds Wroclaw ( Site 2211) - Wroclaw, Lower Silesian Voivodeship, Poland
- Centrum Medyczne Oporow ( Site 2212) - Wroclaw, Lower Silesian Voivodeship, Poland
- Melita Medical Sp. z o.o. ( 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
- 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
- EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202) - Warsaw, Masovian Voivodeship, Poland
- Vivamed Sp. z o.o. ( Site 2201) - Warsaw, Masovian Voivodeship, Poland
Showing 60 of 74 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →