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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1881

Study ID:

NCT01708629

Recruitment Status:

Terminated

Sponsor:

Bausch Health Americas, Inc.

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There are 157 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1881

Study ID:

NCT01708629

Recruitment Status:

Terminated

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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