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

A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease

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

In plain English

AI plain-English summary

People with moderately to severely active Crohn’s disease will swallow one of three doses of an experimental oral drug, TAK-279, or a placebo daily for up to a year to see if it heals their inflamed bowel tissue. Crohn’s disease is a chronic inflammatory condition that causes diarrhoea, bleeding, and abdominal pain. Current treatments do not work for everyone, and there is no cure. This trial tests whether TAK-279, taken as capsules, can reduce inflammation and ulcers in the bowel more effectively than a placebo after 12 weeks, and whether it is safe to take over 52 weeks. The study is double-blind, so neither patients nor doctors know who gets which dose. If TAK-279 proves effective and safe, it could become a new oral treatment option for people whose Crohn’s disease flares up despite existing therapies. That would matter because oral medications are easier to take than injections or infusions, potentially improving daily life for patients who currently rely on more invasive treatments. The trial also compares three dose levels, which could help doctors tailor therapy to individual needs.

View original technical description
Crohn’s disease (CD) is a serious, long-term condition that can cause swelling (inflammation) & painful ulcers anywhere in the gut but most commonly in the bowel. Common symptoms include diarrhoea, bleeding, & abdominal pain. There is no known cure, but some treatments can reduce inflammation & decrease the chances of it coming back. TAK-279 is a potential treatment for CD taken as capsules by mouth. In this study, participants with CD who are having flareups (moderately to severely active CD) will be included in the study. They will either take 1 of 3 doses of TAK-279 or a placebo once a day for up to 52 weeks (1 year), there will also be a screening & follow up period to the study meaning the total time a participant can be in the study is 60 weeks (around 1 year and 2 months). The main aims of the study are to learn if the 3 different doses of TAK-279 reduce inflammation & ulcers in the bowel compared to the placebo after 12 weeks of treatment & to compare any medical problems that participants have when taking TAK-279 or placebo & how well the participants tolerate any problems. This is a double-blind study. 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 4 study treatments by chance. The 4 study treatments are TAK-279 at 3 doses (low, middle, &high doses) & placebo. Participants will take 3 capsules once a day for up to 52 weeks (1 year). After 12 weeks of treatment, if participants taking the placebo have their disease getting worse, they will be switched to the middle dose of TAK-279. Participants taking TAK279 will continue taking their assigned dose for the rest of their treatment in the study. There will be a safety follow-up visit 4 weeks after their last day of treatment.

Researchers

Sreedhar Subramanian (Principal Investigator)

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