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

View Full Description

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.

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:

1831

Study ID:

NCT01708603

Recruitment Status:

Terminated

Sponsor:

Bausch Health Americas, Inc.

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There are 152 Locations for this study

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Birmingham Alabama, 35233, United States
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Tucson Arizona, 85710, United States
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Hot Springs Arkansas, 71913, United States
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Bakersfield California, 93309, United States
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Beverly Hills California, 90211, United States
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Irvine California, 92697, United States
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Los Angeles California, 90027, United States
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Los Angeles California, 90045, United States
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Sacramento California, 95816, 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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Vista California, 92083, United States
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Denver Colorado, 80209, United States
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Denver Colorado, 80210, United States
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Denver Colorado, 80239, United States
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New Haven Connecticut, 06511, United States
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Aventura Florida, 33180, United States
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Jacksonville Florida, 32216, United States
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Miami Florida, 33136, United States
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Pembroke Pines Florida, 33028, United States
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Tampa Florida, 33612, United States
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Atlanta Georgia, 30342, United States
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Newnan Georgia, 30263, United States
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Snellville Georgia, 30078, United States
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Chicago Illinois, 60611, United States
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Chicago Illinois, 60654, United States
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Skokie Illinois, 60077, United States
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Carmel Indiana, 46032, United States
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Plainfield Indiana, 46168, United States
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South Bend Indiana, 46617, United States
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Louisville Kentucky, 40202, United States
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Lake Charles Louisiana, 70601, United States
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Lake Charles Louisiana, 70605, United States
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New Orleans Louisiana, 70112, United States
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Rockville Maryland, 20850, United States
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Silver Spring Maryland, 20902, United States
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Boston Massachusetts, 02114, United States
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Boston Massachusetts, 02115, United States
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North Andover Massachusetts, 01845, United States
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Ann Arbor Michigan, 48109, United States
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Fridley Minnesota, 55432, United States
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Omaha Nebraska, 68144, United States
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Henderson Nevada, 89074, United States
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Brooklyn New York, 11209, United States
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New York New York, 10029, United States
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Rochester New York, 14625, United States
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Charlotte North Carolina, 28210, United States
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Durham North Carolina, 27710, United States
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Raleigh North Carolina, 27612, United States
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Winston-Salem North Carolina, 27103, United States
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Beachwood Ohio, 44122, United States
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Columbus Ohio, 43212, United States
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Gahanna Ohio, 43230, United States
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South Euclid Ohio, 44118, United States
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Portland Oregon, 97239, United States
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Pittsburgh Pennsylvania, 15213, United States
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Anderson South Carolina, 29621, United States
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Mount Pleasant South Carolina, 29464, United States
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Austin Texas, 78759, United States
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Dallas Texas, 75246, United States
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Houston Texas, 77065, United States
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San Antonio Texas, 78229, United States
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San Antonio Texas, 78249, United States
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West Jordan Utah, 84088, United States
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Norfolk Virginia, 23502, United States
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Roanoke Virginia, 24016, United States
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Seattle Washington, 98101, United States
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Phillip Australian Capital Territory, 2606, Australia
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Kogarah New South Wales, 2217, Australia
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Benowa Queensland, 4217, Australia
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Gold Coast Queensland, 4217, Australia
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Woolloongabba Queensland, 4102, Australia
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Box Hill Victoria, 3128, Australia
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Carlton Victoria, 3053, Australia
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Parkville Victoria, 3050, Australia
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Linz , 4020, Austria
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Wien , 1030, Austria
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Wien , 1090, Austria
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Wien , 1130, Austria
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Calgary Alberta, T3A 2, Canada
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Edmonton Alberta, T5K 1, Canada
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Surrey British Columbia, V3R 6, Canada
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Vancouver British Columbia, V5Z 3, Canada
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Ajax Ontario, L1S 7, Canada
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Mississauga Ontario, L5H 1, Canada
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Oakville Ontario, L6J 7, Canada
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Ottawa Ontario, K2G 6, Canada
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Peterborough Ontario, K9J 1, Canada
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Sudbury Ontario, P3E 1, Canada
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Waterloo Ontario, N2J 1, Canada
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Windsor Ontario, N8W 1, Canada
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Windsor Ontario, N8W 5, Canada
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Montreal Quebec, H3H 1, Canada
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Brno , 656 9, Czechia
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Jihlava , 586 3, Czechia
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Novy Jicin , 741 0, Czechia
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Praha 10 , 100 3, Czechia
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Praha 5 , 150 0, Czechia
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Praha 8 , 180 8, Czechia
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Usti nad Labem , 401 1, Czechia
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Amiens Cedex 1 , 80504, France
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Besancon Cedex , 25030, France
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Brest Cedex , 29609, France
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Clermont-Ferrand , 63000, France
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Marseille cedex 05 , 13385, France
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Montpellier cedex 5 , 34295, France
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Paris Cedex 10 , 75475, France
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Pessac Cedex , 33604, France
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Pierre-Bénite , 69495, France
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Rouen Cedex , 76031, France
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Budapest , 1036, Hungary
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Debrecen , 4012, Hungary
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Kecskemet , 6000, Hungary
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Miskolc , 3529, Hungary
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Nyiregyhaza , 4400, Hungary
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Veszprem , 8200, Hungary
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Amsterdam , 1105 , Netherlands
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Breda , 4818 , Netherlands
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Nijmegen , 6525 , Netherlands
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Rotterdam , 3015 , Netherlands
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Gdynia , 81-38, Poland
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Katowice , 40-04, Poland
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Lodz , 90-26, Poland
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Lodz , 90-43, Poland
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Lublin , 20-08, Poland
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Szczecin , 70-33, Poland
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Tarnow , 33-10, Poland
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Warszawa , 02-10, Poland
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Warszawa , 04-14, Poland
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Wroclaw , 50-08, Poland
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Wroclaw , 50-36, Poland
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Wroclaw , 51-15, Poland
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Wroclaw , 51-31, Poland
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Wroclaw , 53-65, Poland
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Coimbra , 3000-, Portugal
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Lisboa , 1649-, Portugal
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Porto , 4050, Portugal
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Porto , 4200-, Portugal
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Cordoba AndalucÃ-a, 14004, Spain
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Córdoba AndalucÃ-a, 14004, Spain
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Sevilla AndalucÃ-a, 41009, Spain
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Alcañiz Aragón, 44600, Spain
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Manacor Baleares, 07500, Spain
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Badalona Cataluña, 08916, Spain
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Barcelona Cataluña, 08003, Spain
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Barcelona Cataluña, 08025, Spain
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Barcelona Cataluña, 08036, Spain
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Barcelona Cataluña, 08041, Spain
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Valencia Comunidad Valenciana, 46014, Spain
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A Coruña Galicia, 15001, Spain
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Alcorcon Madrid, 28922, Spain
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Madrid , 28006, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

1831

Study ID:

NCT01708603

Recruitment Status:

Terminated

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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