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

A Phase 2, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Ulcerative Colitis

Funder NIHR (part of DHSC)
Recipient organisation NIHR Cambridge Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Aug 2027

In plain English

AI plain-English summary

A daily capsule of TAK-279 is being tested against a placebo in 207 adults with moderately to severely active ulcerative colitis to see if it can calm bowel inflammation and stop symptoms like bloody diarrhoea and abdominal pain. Ulcerative colitis is a lifelong inflammatory bowel disease with no cure. Current treatments often fail or lose effectiveness over time, leaving many patients cycling through flare-ups without reliable remission. This trial tests whether TAK-279, an oral drug that blocks a specific inflammatory pathway, can induce remission faster and more consistently than existing options. If TAK-279 proves effective, patients could gain a new, convenient pill-based treatment that reduces the need for injections, hospitalisations, or surgery. The study also includes a 52-week extension where all participants receive the lower dose, which will reveal whether the drug maintains remission long-term. Success would directly improve daily life for people with ulcerative colitis by offering a durable, at-home option to control a chronic condition that otherwise disrupts work, sleep, and social activities.

View original technical description
Ulcerative colitis is a chronic (lifelong) condition of the large intestine or bowel. It is characterised by inflammation of the lining of the bowel that can lead to ulceration, bleeding and at times narrowing and even cancer. The inflammation drives symptoms of diarrhoea, fatigue, blood in the stool and abdominal pain. There is no known cure but treatments aim to induce remission (symptoms disappear) and prevent or reduce relapse also known as flares of the disease (when symptoms come back). TAK-279 is a potential treatment for UC taken as capsules by mouth. Participants with UC who are having flare-ups (moderately to severely active UC) will be asked to take part in this study. They will either take 1 of 2 doses of TAK-279 (lower or higher dose) or a placebo once a day for up to 12 weeks. The placebo looks like the TAK-279 capsule but does not have any medicine in it. This is a double-blind study for up to 12 weeks. This means that neither the participants nor the study doctors will know which treatment each participant is taking. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 30 days. If participants meet the study rules, they will be assigned to 1 of 3 study treatments by chance. The 3 study treatments are TAK-279 at 2 different doses and the placebo. They will either take a lower or higher dose of TAK-279 or a placebo once a day for up to 12 weeks. After 12 weeks, all the participants, including those who received placebo, will receive the lower dose of TAK-279 for the rest of their treatment period through Week 52. There will be a safety follow-up visit 4 weeks after their last day of treatment. This study will have about 207 people participating between the ages of 18 & 75. The study will take place at about 100 hospitals or clinics in approximately 17 countries globally. The main aim is to learn if TAK-279 reduces bowel inflammation and symptoms, compared to the placebo.

Researchers

Sreedhar Subramanian (Principal Investigator)

Related Research

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A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis
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Original classification

Immunity, Inflammation and Transplantation

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