Active Digestion, Kidneys & Other Organs NIHR-supported project Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Crohn's Disease.

Funder NIHR (part of DHSC)
Recipient organisation NIHR University College London Hospitals Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Sept 2028

In plain English

AI plain-English summary

Around 1,200 people with moderate to severe Crohn’s disease will receive either the experimental drug tulisokibart or a placebo to see if the drug can push their symptoms into remission. Crohn’s disease is a chronic inflammatory bowel condition that causes pain, diarrhoea, fatigue, and weight loss. Existing treatments often stop working or cause side effects, leaving many patients cycling between flare-ups and incomplete relief. This trial tests whether tulisokibart—a monoclonal antibody targeting a protein involved in gut inflammation—can offer a new option for those who have not responded to other therapies. If the drug proves effective, it could give patients a longer-lasting remission and reduce the need for hospitalisations or surgery. The study includes a three-year extension for those who improve, which would provide real-world data on durability. For a disease that disrupts daily life unpredictably, a reliable treatment would mean fewer missed workdays, less pain, and better long-term health outcomes. The trial runs for about four years, with participants providing blood, stool, and tissue samples to track biological responses.

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.

Researchers

Paul Harrow (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
MK7240-008 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
Mk7240-008
MK7240-001 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis

Original classification

Infection, Immunopathology & Immunotherapeutics

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.