A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Ulcerative Colitis (NCT06254950)

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.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Miles Sparrow

Key inclusion data

Inclusion Criteria: Male or female aged 18-75 years old with diagnosis of UC for at least 30 days; 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. Exclusion Criteria: 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.