Tulisokibart Long-term Extension Study in Participants With CD or UC
Research type
Research Study
Full title
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn’s Disease or Ulcerative Colitis
IRAS ID
1010609
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for new ways to treat people with Crohn’s disease (CD) or ulcerative colitis (UC). CD and UC cause swelling and ulcers (sores) in the digestive tract.
Tulisokibart (also known as MK-7240) is a study medicine designed to treat active,moderate to severe CD and UC. This study is an extension study, which means 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 and if people tolerate it.
People with CD or UC will be in this study. They:
• Were part of a certain CD or UC parent study on tulisokibart
• Finished treatment and any tests and procedures from the parent study
People will receive tulisokibart at different dosing intervals. Depending on the treatment groups,people will receive tulisokibart or tulisokibart and placebo (looks like the study medicine but has no study medicine in it) as an injection under the skin.
Study staff will train people how to give themselves the injections.
People will be assigned to one of four groups based on the parent study they were in and receive treatment for up to 7 years:
• Group 1 (open-label) will receive tulisokibart less often
• Group 2 (open-label) will receive tulisokibart more often
• Group 3 (double-blind) will receive tulisokibart more often
• Group 4 (double-blind) will receive tulisokibart or placebo more often. People will switch to the other treatment each time.
Some people may change to receive tulisokibart (open-label) more often based on their symptoms and any signs of CD or UC.
During the study, people may give blood,stool,and urine samples. They will also answer questions about how they feel, have physical examinations and have imaging tests, which includes an endoscopy (a test that uses a camera to look at the inside of a person’s digestive tract).
People may be in the study for up to 7 years plus 4 months for follow up.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0721
Date of REC Opinion
4 Dec 2024
REC opinion
Further Information Favourable Opinion