Extension Study to Evaluate Long-term Safety and Efficacy of Tulisokibart in People With Crohns Disease or Ulcerative Colitis

What this Trial Is About

Researchers are studying tulisokibart also known as MK-7240, a medicine designed to treat active, moderate to severe Crohns disease CD and ulcerative colitis UC. This extension study allows people who have already received tulisokibart in certain previous studies for CD or UC to continue in order to learn more about the long-term safety and how well people tolerate this medicine. The study is led by Merck Sharp Dohme LLC and is in Phase 3. Participants receive tulisokibart through injections under the skin. There are different groups receiving either low or high doses, with some doses given openly and others in a blinded manner where participants and researchers do not know which dose is given. This allows comparison of how different doses work and their safety over time. The study lasts up to approximately 378 weeks, which is about 7 years. During the study, participants are regularly monitored for any side effects and whether they stop treatment due to these effects. Researchers also assess disease symptoms such as remission rates using scores for Crohns disease and ulcerative colitis at week 364. Participants undergo clinical evaluations and safety checks throughout the study period. The goal is to understand the long-term effects and safety of tulisokibart while participants continue their usual care.

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