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TAK-279-UC-2001
Recruiting

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

Clinicaltrials.gov
#NCT06254950
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About this clinical trial

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.

US
PL
DE
19+
Interventional Phase 2 clinical trial.

At a glance

What medical conditions are being studied?

Ulcerative Colitis

What is the clinical trial testing?

Placebo, TAK-279

How many participants are being enrolled?

207

Are placebos part of the clinical trial?

Yes

When is the clinical trial being conducted?

Mar 2024 - Aug 2027

How long is participation in the clinical trial?

Participants can be in this study for up to 60 weeks (approximately 1 year and 2 months).

Key requirements

Sexes

All

Age

18 to 75 Years

Healthy volunteers?

No

Entry 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.
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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