Home / TAK-279-CD-2001
TAK-279-CD-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 Crohn's Disease

Clinicaltrials.gov
#NCT06233461
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About this clinical trial

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 after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.

US
PL
JP
22+
Interventional Phase 2 clinical trial.

At a glance

What medical conditions are being studied?

Crohn's Disease

What is the clinical trial testing?

Placebo, TAK-279

How many participants are being enrolled?

268

Are placebos part of the clinical trial?

Yes

When is the clinical trial being conducted?

Mar 2024 - Jul 2027

How long is participation in the clinical trial?

Participants can be in this study for up to 56 weeks (1 year and 1 month).

Key requirements

Sexes

All

Age

18 to 75 Years

Healthy volunteers?

No

Entry criteria

Men and women aged 18 to 75 years can participate in the study. Except in South Korea, the age requirement is more than 19 years.
Must have had moderately to severely active Crohn’s disease which was diagnosed for at least 30 days before study start.
Must be willing to have a colonoscopy to check the bowels and take small samples of tissue (biopsy) 3 times throughout the study. In this procedure, a small flexible tube with a camera on the end will check the bowel.
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.
Cannot have complications of Crohn’s disease which might require surgery during the study.
Additional entry criteria will be discussed with the study doctor.

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