Psoriasis Clinical Trial
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
Summary
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.
Full Description
This study 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 157 Locations for this study
Birmingham Alabama, 35205, United States
Mobile Alabama, 36608, United States
Phoenix Arizona, 85023, United States
Beverly Hills California, 90212, United States
Burbank California, 91505, United States
Encino California, 91436, United States
Fremont California, 94538, United States
Fullerton California, 92835, United States
Irvine California, 92614, United States
Los Angeles California, 90036, United States
Riverside California, 92505, United States
Sacramento California, 95819, United States
San Diego California, 92103, United States
San Diego California, 92123, United States
San Francisco California, 94118, United States
Denver Colorado, 80220, United States
Farmington Connecticut, 06030, United States
Trumbull Connecticut, 06611, United States
Boca Raton Florida, 33486, United States
Coral Gables Florida, 33134, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32204, United States
Miami Florida, 33144, United States
Ocala Florida, 34471, United States
Tamarac Florida, 33321, United States
Alpharetta Georgia, 30022, United States
Atlanta Georgia, 30327, United States
Macon Georgia, 31217, United States
Boise Idaho, 83704, United States
Arlington Heights Illinois, 60005, United States
Champaign Illinois, 61820, United States
Maywood Illinois, 60153, United States
Normal Illinois, 61761, United States
Wheaton Illinois, 60189, United States
Indianapolis Indiana, 46256, United States
New Albany Indiana, 47150, United States
Overland Park Kansas, 66202, United States
Overland Park Kansas, 66215, United States
Louisville Kentucky, 40217, United States
Owensboro Kentucky, 42303, United States
Worcester Massachusetts, 01605, United States
Ann Arbor Michigan, 48103, United States
Clarkston Michigan, 48346, United States
Clinton Township Michigan, 48038, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89144, United States
East Windsor New Jersey, 08520, United States
Hoboken New Jersey, 07030, United States
Verona New Jersey, 07044, United States
Bronx New York, 10467, United States
New York New York, 10016, United States
Rochester New York, 14623, United States
High Point North Carolina, 27262, United States
Cincinnati Ohio, 45249, United States
Cleveland Ohio, 44106, United States
Lake Oswego Oregon, 97035, United States
Portland Oregon, 97210, United States
Exton Pennsylvania, 19341, United States
Johnston Rhode Island, 02919, United States
Greer South Carolina, 29650, United States
Bartlett Tennessee, 38134, United States
Nashville Tennessee, 37205, United States
Bellaire Texas, 77401, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Houston Texas, 77004, United States
Houston Texas, 77030, United States
Houston Texas, 77082, United States
Webster Texas, 77598, United States
Salt Lake City Utah, 84132, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23294, United States
Spokane Washington, 99204, United States
Clarksburg West Virginia, 26301, United States
Camperdown New South Wales, 2050, Australia
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
St Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2000, Australia
Westmead New South Wales, 2145, Australia
Hectorville South Australia, 5073, Australia
Fremantle Western Australia, 6160, Australia
Brugge , 8000, Belgium
Brussels , 1200, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Montigny-le-Tilleul , 6110, Belgium
Calgary Alberta, T2G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Winnipeg Manitoba, R3C 0, Canada
Winnipeg Manitoba, R3C 1, Canada
St. John's Newfoundland and Labrador, A1A 4, Canada
St. John's Newfoundland and Labrador, A1A 5, Canada
Halifax Nova Scotia, B3H 0, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8N 1, Canada
Markham Ontario, L3P 1, Canada
Richmond Hill Ontario, L4B 1, Canada
Toronto Ontario, M3H 5, Canada
Toronto Ontario, M5S 3, Canada
Toronto Ontario, M8X 1, Canada
Drummondville Quebec, J2B 5, Canada
Montreal Quebec, H3Z 2, Canada
Saint-Hyacinthe Quebec, J2S 6, Canada
Créteil , 94010, France
Limoges , 87000, France
Nice , 06200, France
Poitiers , 86000, France
Saint Priest en Jarez , 42270, France
Toulouse Cedex 9 , 31059, France
Vandoeuvre les Nancy , 54511, France
Chaïdári Athens, 12462, Greece
Athens , 16121, Greece
Ioannina , 45500, Greece
Larissa , 41110, Greece
Maroussi , 15123, Greece
Thessaloniki , 54643, Greece
Thessaloniki , 56429, Greece
Bekescsaba , 5600, Hungary
Budapest , 1085, Hungary
Gyula , 5700, Hungary
Szeged , 6720, Hungary
Szolnok , 5000, Hungary
Szombathely , 9700, Hungary
Bologna , 40138, Italy
Genova , 16132, Italy
Milano , 20122, Italy
Milano , 48018, Italy
Roma , 00133, Italy
Roma , 00168, Italy
Riga , 1001, Latvia
Riga , 1003, Latvia
Riga , LV-10, Latvia
Ventspils , 3601, Latvia
Bialystok , 15-87, Poland
Dąbrówka , 62-06, Poland
Gdansk , 80-95, Poland
Iwonicz Zdroj , 38-44, Poland
Katowice , 40-95, Poland
Krakow , 30-51, Poland
Kraków , 31-50, Poland
Lodz , 90-24, Poland
Lublin , 20-40, Poland
Poznan , 60-53, Poland
Stalowa-Wola , 37-45, Poland
Swidnik , 21-04, Poland
Warszawa , 01-19, Poland
Warszawa , 02-20, Poland
Ekaterinburg , 62007, Russian Federation
Moscow , 10707, Russian Federation
Moscow , 11999, Russian Federation
Moscow , 12161, Russian Federation
Saint-Petersburg , 19404, Russian Federation
Saratov , 41002, Russian Federation
St. Petersburg , 19101, Russian Federation
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