A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

In plain English

What this trial is testing

This study is testing TAK-279 (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 75
• Any sex

Some of the main requirements, copied from the record:

• Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is >=19 years of age.
• Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
• Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.

There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 268 participants are expected to take part.
• The study has 4 groups.
• Start date: 2024-03-05.
• Main results expected around 2027-02-17 (estimate from the record).
• 201 study sites listed (189 marked recruiting) in Australia, Belgium, Brazil, Bulgaria and Canada and 20 more countries.

Groups in this study

• TAK-279 Dose 1 (listed as: experimental group)
• TAK-279 Dose 2 (listed as: experimental group)
• TAK-279 Dose 3 (listed as: experimental group)
• Placebo (listed as: experimental group)

Main thing being measured

• Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 (Week 12)

In the researchers’ words

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo…

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.