A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 61 weeks.
The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.
The study will enroll approximately 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
This multi-center trial will be conducted worldwide. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 52 weeks (1 year). There will be a safety follow-up visit 4 weeks after their last day of treatment.
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply.
Indianapolis, Indiana 46256-4697, United States
New York, New York 10003-3314, United States
Kogarah, New South Wales 2217, Australia
North York, Ontario M2M 4J5, Canada
Beijing, Beijing Municipality 100050, China
Chongqing, Chongqing Municipality 400016, China
Wuhan, Hubei, China
Wenzhou, Zhejiang 325000, China
Obihiro-Shi, Hokkaidô 080-0013, Japan
Isehara-Shi, Kanagawa 259-1143, Japan
Shimotsuke-Shi, Tochigi 329-0431, Japan
Itabashi-Ku, Tokyo 173-0003, Japan
Shinjuku-Ku, Tokyo 160-0023, Japan
Shinjuku-Ku, Tokyo 169-0073, Japan
Sumida-Ku, Tokyo, Japan
Poznan, Greater Poland Voivodeship 60-702, Poland
Wroclaw, Lower Silesian Voivodeship 50-566, Poland
Lódz, Lódzkie 90-436, Poland
Gdansk, Pomeranian Voivodeship 80-382, Poland
Gdansk, Pomeranian Voivodeship 80-462, Poland
Lodz, 90-647, Poland
Savannah, Georgia 31419-1768, South Korea
Bucheon-si, Gyeonggido 14647, South Korea
Bundang-Gu Seongnam-Si, Gyeonggido 13496, South Korea
Bundang-Gu, Gyeonggido 13620, South Korea
Gwangjin-Gu, Seoul Teugbyeolsi 05030, South Korea
Jongno-Gu, Seoul Teugbyeolsi 03080, South Korea
Seocho-Gu, Seoul Teugbyeolsi 06591, South Korea
Zhong Zheng Qu, 100, Taiwan