What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called tulisokibart (MK-7240) compared with placebo (inactive substance) in people with Crohn’s disease or ulcerative colitis. The study focuses on patients who were in a previous trial of tulisokibart for Crohn’s disease or ulcerative colitis and may benefit from continuing to receive the drug. Tulisokibart has the potential to improve inflammatory and fibrotic (thickening or scarring) diseases related to the immune system. Tulisokibart will be administered by injection subcutaneously (under the skin). Procedures include physical exams, laboratory tests, endoscopies, and completion of questionnaires. Researchers aim to assess the long-term safety of tulisokibart and determine how well it works over time.
Eligibility
- * 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
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn?s Disease or Ulcerative Colitis