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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

18-75 Years
18 to 75 Years
All
All

Not accepting

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?

Yes

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.
No

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.

Locations

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Withdrawn
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Withdrawn

For more information, view the full study details:

NCT06254950jRCT2031240228