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.

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

661

Study ID:

NCT01708590

Recruitment Status:

Terminated

Sponsor:

Bausch Health Americas, Inc.

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There are 78 Locations for this study

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Research Site
Phoenix Arizona, 85023, United States
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Bakersfield California, 93301, United States
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Encino California, 91436, United States
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Los Angeles California, 90045, 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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San Ramon California, 94583, United States
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Santa Monica California, 90404, United States
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Alpharetta Georgia, 30022, United States
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West Dundee Illinois, 60118, United States
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Richmond Kentucky, 40475, United States
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Columbia Maryland, 21045, United States
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Boston Massachusetts, 02111, United States
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Fort Gratiot Michigan, 48059, United States
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Saint Louis Missouri, 63104, United States
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Saint Louis Missouri, 63117, United States
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Saint Louis Missouri, 63141, United States
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Omaha Nebraska, 68131, United States
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Buffalo New York, 14221, United States
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Forest Hills New York, 11375, United States
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Rochester New York, 14618, United States
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Stony Brook New York, 11790, United States
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Wilmington North Carolina, 28401, United States
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Cleveland Ohio, 44106, United States
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Portland Oregon, 97223, United States
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Rapid City South Dakota, 57702, United States
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Goodlettsville Tennessee, 37072, United States
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Nashville Tennessee, 37215, United States
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Arlington Texas, 76011, United States
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Austin Texas, 78759, United States
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Dallas Texas, 75231, United States
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Houston Texas, 77030, United States
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San Antonio Texas, 78229, United States
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Surrey British Columbia, V3R 6, Canada
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Moncton New Brunswick, E1C 8, Canada
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Halifax Nova Scotia, B3H 0, Canada
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London Ontario, N6A 3, Canada
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North Bay Ontario, P1B 3, Canada
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Sudbury Ontario, P3C 1, Canada
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Waterloo Ontario, N2J 1, Canada
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Windsor Ontario, N8W 1, Canada
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Montreal Quebec, H2K 4, Canada
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Quebec , G1V 4, Canada
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Nice , 06200, France
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Pessac Cedex , 33604, France
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Saint Priest en Jarez , 42270, France
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Toulouse Cedex 9 , 31059, France
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Berlin , 10117, Germany
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Berlin , 13507, Germany
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Blankenfelde , 15831, Germany
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Bochum , 44803, Germany
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Bonn , 53105, Germany
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Buchholz , 21244, Germany
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Dülmen , 48249, Germany
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Frankfurt am Main , 60590, Germany
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Friedrichshafen , 88045, Germany
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Halle (Saale) , 06120, Germany
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Hamburg , 20246, Germany
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Hamburg , 20354, Germany
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Kiel , 24105, Germany
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Münster , 48149, Germany
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Osnabrück , 49074, Germany
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Iwonicz Zdroj , 38-44, Poland
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Lodz , 90-26, Poland
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Lodz , 90-43, Poland
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Olsztyn , 10-22, Poland
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Poznan , 60-53, Poland
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Szczecin , 70-11, Poland
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Toruń , 87-10, Poland
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Warszawa , 01-19, Poland
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Wroclaw , 50-08, Poland
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Wroclaw , 50-36, Poland
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Wroclaw , 51-31, Poland
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Basel , 4031, Switzerland
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Bern , 3010, Switzerland
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Geneva 14 , 1211, Switzerland
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Lausanne , 1011, Switzerland
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Zürich , 8091, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

661

Study ID:

NCT01708590

Recruitment Status:

Terminated

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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