A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.

Key facts

Study ID

NCT06254950

Run by

Takeda

People needed

207

Starts

2024-03-29

Expected to finish

2027-08-04

Last updated by the study team

2026-05-06

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 UC 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 UC assessed by mMS and ES.
• Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
• Participants must meet the contraception recommendations.

You may not qualify if…

• Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
• Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
• Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
• Participants who have failed 3 or more classes of advanced therapies.

Where it is running

• United Medical Doctors — Murrieta, California, United States
• West Central Gastroenterology, LLP, d/b/a/ Gastro Florida — Clearwater, Florida, United States
• Auzmer Research — Lakeland, Florida, United States
• GI PROS, Inc. — Naples, Florida, United States
• USF Health Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• Emory University Hospital, The Emory Clinic — Atlanta, Georgia, United States
• Atlanta Center For Gastroenterology, P.C. — Decatur, Georgia, United States
• University Of Louisville — Louisville, Kentucky, United States
• Woodholme Gastroenterology Associates — Glen Burnie, Maryland, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• University Gastroenterology — Providence, Rhode Island, United States
• Gastroenterology Associates, PA — Greenville, South Carolina, United States
• Novel Research, LLC — Bellaire, Texas, United States
• Tyler Research Institute, LLC — Tyler, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Concord Repatriation General Hospital — Sydney, New South Wales, Australia
• Mater Cancer Care Centre-Mater Health Services — South Brisbane, Queensland, Australia
• Flinders Medical Centre — Bedford Park, South Australia, Australia
• The Queen Elizabeth Hospital — Woodville, South Australia, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Western Health/Footscray Hospital — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital Lung Institute Of Western Australia — Nedlands, Western Australia, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• Harry Perkins Medical Research Institute Fiona Stanley Hospital — Murdoch, Australia
• GastroIntestinal BioSciences — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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