Psoriasis Clinical Trial
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
Summary
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
Full Description
.The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
Eligibility Criteria
Inclusion Criteria:
Subject has had stable moderate to severe plaque psoriasis for at least 6 months
Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline
Exclusion Criteria:
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
Subject has known history of Crohn's disease
Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
Subject has not stopped using certain psoriasis therapies as defined in the study protocol
Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
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There are 152 Locations for this study
Birmingham Alabama, 35233, United States
Tucson Arizona, 85710, United States
Hot Springs Arkansas, 71913, United States
Bakersfield California, 93309, United States
Beverly Hills California, 90211, United States
Irvine California, 92697, United States
Los Angeles California, 90027, United States
Los Angeles California, 90045, United States
Sacramento California, 95816, United States
San Diego California, 92103, United States
San Diego California, 92123, United States
Vista California, 92083, United States
Denver Colorado, 80209, United States
Denver Colorado, 80210, United States
Denver Colorado, 80239, United States
New Haven Connecticut, 06511, United States
Aventura Florida, 33180, United States
Jacksonville Florida, 32216, United States
Miami Florida, 33136, United States
Pembroke Pines Florida, 33028, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30342, United States
Newnan Georgia, 30263, United States
Snellville Georgia, 30078, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60654, United States
Skokie Illinois, 60077, United States
Carmel Indiana, 46032, United States
Plainfield Indiana, 46168, United States
South Bend Indiana, 46617, United States
Louisville Kentucky, 40202, United States
Lake Charles Louisiana, 70601, United States
Lake Charles Louisiana, 70605, United States
New Orleans Louisiana, 70112, United States
Rockville Maryland, 20850, United States
Silver Spring Maryland, 20902, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
North Andover Massachusetts, 01845, United States
Ann Arbor Michigan, 48109, United States
Fridley Minnesota, 55432, United States
Omaha Nebraska, 68144, United States
Henderson Nevada, 89074, United States
Brooklyn New York, 11209, United States
New York New York, 10029, United States
Rochester New York, 14625, United States
Charlotte North Carolina, 28210, United States
Durham North Carolina, 27710, United States
Raleigh North Carolina, 27612, United States
Winston-Salem North Carolina, 27103, United States
Beachwood Ohio, 44122, United States
Columbus Ohio, 43212, United States
Gahanna Ohio, 43230, United States
South Euclid Ohio, 44118, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15213, United States
Anderson South Carolina, 29621, United States
Mount Pleasant South Carolina, 29464, United States
Austin Texas, 78759, United States
Dallas Texas, 75246, United States
Houston Texas, 77065, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78249, United States
West Jordan Utah, 84088, United States
Norfolk Virginia, 23502, United States
Roanoke Virginia, 24016, United States
Seattle Washington, 98101, United States
Phillip Australian Capital Territory, 2606, Australia
Kogarah New South Wales, 2217, Australia
Benowa Queensland, 4217, Australia
Gold Coast Queensland, 4217, Australia
Woolloongabba Queensland, 4102, Australia
Box Hill Victoria, 3128, Australia
Carlton Victoria, 3053, Australia
Parkville Victoria, 3050, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Linz , 4020, Austria
Wien , 1030, Austria
Wien , 1090, Austria
Wien , 1130, Austria
Calgary Alberta, T3A 2, Canada
Edmonton Alberta, T5K 1, Canada
Surrey British Columbia, V3R 6, Canada
Vancouver British Columbia, V5Z 3, Canada
Ajax Ontario, L1S 7, Canada
Mississauga Ontario, L5H 1, Canada
Oakville Ontario, L6J 7, Canada
Ottawa Ontario, K2G 6, Canada
Peterborough Ontario, K9J 1, Canada
Sudbury Ontario, P3E 1, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 1, Canada
Windsor Ontario, N8W 5, Canada
Montreal Quebec, H3H 1, Canada
Brno , 656 9, Czechia
Jihlava , 586 3, Czechia
Novy Jicin , 741 0, Czechia
Praha 10 , 100 3, Czechia
Praha 5 , 150 0, Czechia
Praha 8 , 180 8, Czechia
Usti nad Labem , 401 1, Czechia
Amiens Cedex 1 , 80504, France
Besancon Cedex , 25030, France
Brest Cedex , 29609, France
Clermont-Ferrand , 63000, France
Marseille cedex 05 , 13385, France
Montpellier cedex 5 , 34295, France
Paris Cedex 10 , 75475, France
Pessac Cedex , 33604, France
Pierre-Bénite , 69495, France
Rouen Cedex , 76031, France
Budapest , 1036, Hungary
Debrecen , 4012, Hungary
Kecskemet , 6000, Hungary
Miskolc , 3529, Hungary
Nyiregyhaza , 4400, Hungary
Veszprem , 8200, Hungary
Amsterdam , 1105 , Netherlands
Breda , 4818 , Netherlands
Nijmegen , 6525 , Netherlands
Rotterdam , 3015 , Netherlands
Gdynia , 81-38, Poland
Katowice , 40-04, Poland
Lodz , 90-26, Poland
Lodz , 90-43, Poland
Lublin , 20-08, Poland
Szczecin , 70-33, Poland
Tarnow , 33-10, Poland
Warszawa , 02-10, Poland
Warszawa , 04-14, Poland
Wroclaw , 50-08, Poland
Wroclaw , 50-36, Poland
Wroclaw , 51-15, Poland
Wroclaw , 51-31, Poland
Wroclaw , 53-65, Poland
Coimbra , 3000-, Portugal
Lisboa , 1649-, Portugal
Porto , 4050, Portugal
Porto , 4200-, Portugal
Cordoba AndalucÃ-a, 14004, Spain
Córdoba AndalucÃ-a, 14004, Spain
Sevilla AndalucÃ-a, 41009, Spain
Alcañiz Aragón, 44600, Spain
Manacor Baleares, 07500, Spain
Badalona Cataluña, 08916, Spain
Barcelona Cataluña, 08003, Spain
Barcelona Cataluña, 08025, Spain
Barcelona Cataluña, 08036, Spain
Barcelona Cataluña, 08041, Spain
Valencia Comunidad Valenciana, 46014, Spain
A Coruña Galicia, 15001, Spain
Alcorcon Madrid, 28922, Spain
Madrid , 28006, Spain
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