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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT06233461

Run by

Takeda

People needed

268

Starts

2024-03-05

Expected to finish

2027-07-23

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
• 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.

You may not qualify if…

• Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
• Have complications of CD that might require surgery during the study.
• Participants with a current ostomy.
• Participants who have failed 3 or more classes of advanced therapies.

Where it is running

• Southern Star Research Institute, LLC — San Antonio, Texas, United States (enrolling)
• Concord Repatriation General Hospital — Sydney, New South Wales, Australia (enrolling)
• Auzmer Research — Lakeland, Florida, United States (enrolling)
• UCI Health — Orange, California, United States (enrolling)
• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• West Central Gastroenterology, LLP, d/b/a/ Gastro Florida — Clearwater, Florida, United States (enrolling)
• USF Health Morsani Center for Advanced Healthcare — Tampa, Florida, United States (enrolling)
• Emory University Hospital, The Emory Clinic — Atlanta, Georgia, United States (enrolling)
• Atlanta Center For Gastroenterology, P.C. — Decatur, Georgia, United States (enrolling)
• Wellness Clinical Research — Miami Lakes, Florida, United States (enrolling)
• Tyler Research Institute, LLC — Tyler, Texas, United States (enrolling)
• University Of Louisville — Louisville, Kentucky, United States (enrolling)
• Woodholme Gastroenterology Associates — Glen Burnie, Maryland, United States (enrolling)
• BVL Clinical Research — Liberty, Missouri, United States (enrolling)
• Las Vegas Medical Research — Las Vegas, Nevada, United States (enrolling)
• Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) — New York, New York, United States (enrolling)
• Rochester Clinical Research — Rochester, New York, United States (enrolling)
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States (enrolling)
• University Gastroenterology Providence — Providence, Rhode Island, United States (enrolling)
• Gastroenterology Associates, PA — Greenville, South Carolina, United States (enrolling)
• Novel Research, LLC — Bellaire, Texas, United States (enrolling)
• The University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
• GI PROS, Inc. — Naples, Florida, United States (enrolling)
• United Medical Doctors — Murrieta, California, United States (enrolling)
• Mater Cancer Care Centre-Mater Health Services — South Brisbane, Queensland, Australia (enrolling)

Full record on ClinicalTrials.gov

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