A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
Sponsored by Takeda
About this trial
Last updated 2 months ago
Study ID
TAK-279-UC-2001
Status
Recruiting
Type
Interventional
Phase
Phase 2
Placebo
Yes
Accepting
18 to 75 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started a year ago
What is this trial about?
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms
compared to placebo. Another aim is to compare any medical problems that participants
have when they take TAK-279 or placebo and how well the participants tolerate any
problems.
The participants will take capsules of either TAK-279 or placebo for up to 3 months (12
weeks). Then all the participants will receive TAK-279 for the rest of the treatment part
of the study (1 year or 52 weeks).
During the study, participants will visit their study clinic several times.
What are the participation requirements?
Inclusion Criteria
Men and women aged 18 to 75 years (>= 19 years for South Korea) can participate in the study.
Must have had moderately to severely active ulcerative colitis which was diagnosed for at least 30 days before study start.
Must be willing have a colonoscopy to check the bowels and take small samples of tissue (biopsy) during screening. In this procedure, a small flexible tube with a camera on the end will check the bowel and obtain samples.
Must have had problems with standard treatments, or the treatments have not worked well enough.
Exclusion Criteria
Cannot have complications of ulcerative colitis which might require surgery during the study.
Cannot have had a recent infection of have a history of certain infections.
Additional entry criteria will be discussed with the study doctor.
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