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
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
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.
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 -
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.
Inclusion Criteria:
Exclusion Criteria:
Nedlands, Western Australia 6009, Australia
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel 1070, Belgium
Sofia, 1527, Bulgaria
Guangzhou, Guangdong 3011, China
Chongqing, Hubei 430060, China
Shenyang, Liaoning 110022, China
Shanghai, Shanghai Municipality, China
Ostrava-Poruba, 708 00, Czechia
Odense, Region Syddanmark 5000, Denmark
Vandœuvre-lès-Nancy, 54500, France
Hamburg, 20251, Germany
Ramat Gan, 5265601, Israel
Milan, 20132, Italy
Minato-ku, Tokyo 108-8642, Japan
Lorenskog, Akershus 1478, Norway
Torun, Kujawsko-pomo 87-100, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
Szczecin, West Pomeranian Voivodeship 71-434, Poland
Lodz, 90-153, Poland
Cambridge, CB2 0QQ, United Kingdom