TAK-279 for Moderately to Severely Active Crohn's Disease
This study is testing a new medication called TAK-279 to see if it can safely reduce inflammation in people with moderately to severely active Crohn's disease (a long-lasting condition causing gut inflammation). You might be able to join if you are between 18 and 75 years old, have a confirmed diagnosis of Crohn's disease, and haven't responded well to other treatments. The main goal is to find out if TAK-279 can reduce bowel inflammation and ulcers after 12 weeks, compared to a placebo (an inactive pill). Researchers will use an endoscopy (a procedure to look inside your bowel) to check for inflammation. The study is currently recruiting about 268 participants.
- Study design
- This is an interventional study where participants will be randomly assigned to receive one of three doses of TAK-279 or a placebo, with neither you nor your doctor knowing which you receive.
- What's involved
- You will take TAK-279 or placebo capsules for 52 weeks (1 year). An endoscopy will be used to check your bowel for inflammation.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for a 4-week safety period after treatment, making the total study duration about 60 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
190 sites across 87 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12Week 12
Endoscopic response is defined by decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).