A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
Merck Sharp & Dohme LLC
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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…
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
- St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)Ypsilanti, Michigan
- BVL Research - Kansas ( Site 0292)Liberty, Missouri
- New York Gastroenterology Associates ( Site 0253)New York, New York
- GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)Garland, Texas
- GI Alliance - Lubbock ( Site 0288)Lubbock, Texas