NCT06651281

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

A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,380 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Tulisokibart	Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
DRUG	Placebo to tulisokibart	Placebo matching SC tulisokibart

Timeline

• Start date: 2024-11-25
• Primary completion: 2037-12-17
• Completion: 2037-12-17
• First posted: 2024-10-21
• Last updated: 2025-12-26

Locations

37 sites across 7 countries: United States, Czechia, France, Georgia, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study