A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period 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 With a Randomized Withdrawal and Retreatment Period 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 69 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 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. 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 60 weeks. 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.
Los Angeles, California 90017-5310, United States
Clarksville, Indiana 47129-2201, United States
Ann Arbor, Michigan 48109-5360, United States
Winston-Salem, North Carolina 27103-7109, United States
Winston-Salem, North Carolina 27157-0001, United States
Pittsburgh, Pennsylvania 15213-3403, United States
Hermitage, Tennessee 37076-3497, United States
Pflugerville, Texas 78660-6148, United States
Ciudad Autónomade Buenos Aires, C1060ABN, Argentina
Sofia, Sofia-Grad 1606, Bulgaria
Sofia, Sofia-Grad 1606, Bulgaria
Pleven, Bulgaria
Hamilton, Ontario L8L 3C3, Canada
Richmond Hill, Ontario L4C 9M7, Canada
Wuhan, Hubei 430030, China
Nanjing, Jiangsu 210029, China
Hangzhou, Zhejiang 310016, China
Loannina, Loannina 455 00, Greece
Lublin, Lublin Voivodeship 20-573, Poland
Lódz, Lódzkie 90-338, Poland
Warsaw, Masovian Voivodeship 02-672, Poland
Katowice, Silesian Voivodeship 40-040, Poland
Klodzko Dolnoslaskie, 57-300, Poland
High Wycombe, Buckinghamshire HP11 2QW, United Kingdom