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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
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

NCT06233461

RecruitingPhase 2

Sponsor: Takeda

Conditions: Crohn's Disease

Interventions: TAK-279, Placebo

Countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (190)
  • Murrieta, California, United States
  • Orange, California, United States
  • Clearwater, Florida, United States
  • Lakeland, Florida, United States
  • Miami Lakes, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Louisville, Kentucky, United States
  • Glen Burnie, Maryland, United States
  • Liberty, Missouri, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Mentor, Ohio, United States
  • Providence, Rhode Island, United States
  • Greenville, South Carolina, United States
  • Bellaire, Texas, United States
  • Fort Worth, Texas, United States
  • Kingwood, Texas, United States
  • Mansfield, Texas, United States
  • San Antonio, Texas, United States
  • Tyler, Texas, United States
  • Seattle, Washington, United States
  • Sydney, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • + 160 more on CT.gov