Recipient organisationNIHR Exeter Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Aug 2028
In plain English
AI plain-English summary
A new drug called tulisokibart is being tested in 1,200 people with active, moderate to severe Crohn’s disease who have not been helped by other treatments. Crohn’s disease causes painful swelling and ulcers in the digestive tract, leading to diarrhoea, fatigue, and weight loss. Existing treatments fail for many patients, leaving them with persistent symptoms and no good options. This trial directly addresses that gap by testing whether tulisokibart can induce remission or reduce symptoms where other medicines have not worked. If the drug proves effective, it could offer a new treatment pathway for people with hard-to-treat Crohn’s disease. The trial also includes a three-year extension for those who respond, providing data on long-term safety and durability of response. Success would mean a new biological therapy for a condition that currently leaves many patients cycling between flare-ups and inadequate symptom control. The study runs for about four years, collecting blood, urine, stool, and colon tissue samples to understand how the drug works in the body.
View original technical description
Researchers are looking for a new way to treat people with Crohn’s disease (CD) that is causing symptoms (called active). Crohn’s disease (CD) is an inflammatory bowel disease (IBD) that causes swelling and ulcers (sores) in the digestive tract. Symptoms of CD include pain, loose and watery stools (diarrhoea), feeling tired, mouth sores, and weight loss. CD symptoms can come and go, with periods of few or no CD symptoms (called remission) between periods of CD symptoms. Researchers want to learn if tulisokibart, the study medicine, can treat CD. The goals of this study are to learn if more people who receive tulisokibart will go into remission (CD symptoms go away) or respond (CD symptoms lessen or go away) to treatment compared to those who receive placebo (looks like the study medicine but has no study medicine in it). Using a placebo helps researchers better understand the effects of a study treatment. About 1,200 people with active, moderate to severe CD will be in the study. They will be ages 16 to 75 years and:• Have moderate to severe CD based on symptoms, physical examinations, and lab tests• Have had CD for at least 3 months• Have taken other medicines that either did not help their CD or they did not tolerate the medicine• Do not have ulcerative colitis or another type of IBD People will receive one or both treatments: • Tulisokibart, the study medicine, at different dose levels (amounts) • Placebo Both MK-7240 and placebo will be administered as intravenous (IV) infusion or as an injection.This study is made up of 2 studies (Study 1 and Study 2). For both studies, people whose CD symptoms lessen after treatment may continue to receive treatment with tulisokibart for another 3 years (called an extension).Participants will give samples (blood, urine, stool, and colon tissue), have physical examinations, answer questions, and have imaging tests.Participants may be in the study for about 4 years.
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