Psoriasis Clinical Trial
Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
Summary
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
Full Description
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.
Eligibility Criteria
Inclusion Criteria:
Subject has had stable moderate to severe plaque psoriasis for at least 6 months
Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling
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 stopped using certain psoriasis therapies as defined in the study protocol
Subject has previously used any anti-IL-17 biologic therapy
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There are 78 Locations for this study
Phoenix Arizona, 85023, United States
Bakersfield California, 93301, United States
Encino California, 91436, United States
Los Angeles California, 90045, United States
San Diego California, 92123, United States
San Francisco California, 94118, United States
San Ramon California, 94583, United States
Santa Monica California, 90404, United States
Alpharetta Georgia, 30022, United States
West Dundee Illinois, 60118, United States
Richmond Kentucky, 40475, United States
Columbia Maryland, 21045, United States
Boston Massachusetts, 02111, United States
Fort Gratiot Michigan, 48059, United States
Saint Louis Missouri, 63104, United States
Saint Louis Missouri, 63117, United States
Saint Louis Missouri, 63141, United States
Omaha Nebraska, 68131, United States
Buffalo New York, 14221, United States
Forest Hills New York, 11375, United States
Rochester New York, 14618, United States
Stony Brook New York, 11790, United States
Wilmington North Carolina, 28401, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97223, United States
Rapid City South Dakota, 57702, United States
Goodlettsville Tennessee, 37072, United States
Nashville Tennessee, 37215, United States
Arlington Texas, 76011, United States
Austin Texas, 78759, United States
Dallas Texas, 75231, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Surrey British Columbia, V3R 6, Canada
Moncton New Brunswick, E1C 8, Canada
Halifax Nova Scotia, B3H 0, Canada
London Ontario, N6A 3, Canada
North Bay Ontario, P1B 3, Canada
Sudbury Ontario, P3C 1, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 1, Canada
Montreal Quebec, H2K 4, Canada
Quebec , G1V 4, Canada
Nice , 06200, France
Pessac Cedex , 33604, France
Saint Priest en Jarez , 42270, France
Toulouse Cedex 9 , 31059, France
Berlin , 10117, Germany
Berlin , 13507, Germany
Blankenfelde , 15831, Germany
Bochum , 44803, Germany
Bonn , 53105, Germany
Buchholz , 21244, Germany
Dülmen , 48249, Germany
Frankfurt am Main , 60590, Germany
Friedrichshafen , 88045, Germany
Halle (Saale) , 06120, Germany
Hamburg , 20246, Germany
Hamburg , 20354, Germany
Kiel , 24105, Germany
Münster , 48149, Germany
Osnabrück , 49074, Germany
Iwonicz Zdroj , 38-44, Poland
Lodz , 90-26, Poland
Lodz , 90-43, Poland
Olsztyn , 10-22, Poland
Poznan , 60-53, Poland
Szczecin , 70-11, Poland
Toruń , 87-10, Poland
Warszawa , 01-19, Poland
Wroclaw , 50-08, Poland
Wroclaw , 50-36, Poland
Wroclaw , 51-31, Poland
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Geneva 14 , 1211, Switzerland
Lausanne , 1011, Switzerland
Zürich , 8091, Switzerland
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