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A Phase 2b Study Evaluating Safety of Oral TAK-279 in Moderate to Severe Chorn's Disease

UCI Specialty Area: Gastroenterology
Principal Investigator: Robert Fearn
Official Title: A Phase 2b, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn's Disease.
A Study On:
Crohns Disease
Digestive - Gastrointestinal

Study 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):

TAK-279 Dose 1

TAK-279 Dose 2

TAK-279 Dose 3

Placebo

This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

Eligibility

  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 greater or equal to 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.
  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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Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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