NCT06254950

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. An approximate total of eligible 207 participants will be randomized to one of the three treatment groups - 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. Placebo The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	TAK-279	TAK-279 capsules.
DRUG	Placebo	TAK-279 placebo-matching capsules.

Timeline

• Start date: 2024-03-29
• Primary completion: 2026-09-30
• Completion: 2027-08-04
• First posted: 2024-02-12
• Last updated: 2026-04-13

Locations

141 sites across 22 countries: United States, Australia, Belgium, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Norway, Poland, Romania, Slovakia, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study