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About
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 any 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.t
Full description
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279.
The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female aged 18-75 years old with diagnosis of CD for at least 30 days.
Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
Participants must have received prior treatment(s) for CD (according to either (a) or (b) below or a combination of both):
Participants must meet the contraception recommendations.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
268 participants in 4 patient groups
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Central trial contact
Takeda Contact
Data sourced from clinicaltrials.gov
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