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

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust Cambridge Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Feb 2025 — Ongoing

In plain English

AI plain-English summary

A daily capsule of TAK-279 is being tested against placebo in 207 adults with moderately to severely active ulcerative colitis across 100 global sites. Ulcerative colitis is a chronic inflammatory bowel disease with no cure. Current treatments often fail to induce or maintain remission, leaving patients with debilitating symptoms like bloody diarrhoea, fatigue, and abdominal pain. This trial addresses the need for a new oral therapy that is both effective and convenient, avoiding the injections or infusions required by many existing biologics. If TAK-279 reduces bowel inflammation and symptoms better than placebo over 12 weeks, it could offer patients a simple, at-home treatment option to achieve remission and prevent disease flares. The study also tests two dose levels to find the optimal balance of efficacy and safety. After the initial blinded phase, all participants—including those initially on placebo—receive the lower dose through week 52, providing long-term data on sustained disease control. Success would add an oral small-molecule drug to the limited toolkit for managing this lifelong condition.

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)

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