Evaluating TAK-279 for reducing bowel inflammation in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and efficacy of TAK-279 in participants with moderately to severely active Crohn's disease. Participants will be randomly assigned to receive one of three doses of TAK-279 or a placebo over a 52-week period, with their bowel inflammation monitored through endoscopy. The study will involve approximately 268 participants and will include 15 clinic visits to evaluate treatment effects and tolerability. The primary goal is to determine if TAK-279 can effectively reduce bowel inflammation and ulcers compared to placebo.

Why it matters

Who can join: the full rules

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.

Where it's running

• United Medical Doctors
  Murrieta, California, United States Recruiting
• UCI Health
  Orange, California, United States Recruiting
• West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
  Clearwater, Florida, United States Recruiting
• Auzmer Research
  Lakeland, Florida, United States Recruiting
• Wellness Clinical Research
  Miami Lakes, Florida, United States Recruiting
• GI PROS, Inc.
  Naples, Florida, United States Recruiting

+151 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.