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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 Crohn's Disease

RecruitingPhase 2Ages 18 Years - 75 YearsAllTakeda
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age. 2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI. 3. Participants 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. Exclusion Criteria: 1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis. 2. Have complications of CD that might require surgery during the study. 3. Participants with a current ostomy. 4. Participants who have failed 3 or more classes of advanced therapies.
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What it tests

  • TAK-279
  • Placebo
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Where

201 sites
United Medical Doctors
Murrieta, United States
UCI Health
Orange, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, United States
Auzmer Research
Lakeland, United States
Wellness Clinical Research
Miami Lakes, United States
GI PROS, Inc.
Naples, United States
AdventHealth (Florida Hospital) Medical Group
Orlando, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, United States

…and 193 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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