Psoriasis Clinical Trial

Study of Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis

Summary

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

View Full Description

Full Description

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the distal interphalangeal joints)).
Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated CRP.

Exclusion Criteria:

Subject has known history of active tuberculosis.
Subject has a planned surgical intervention between baseline and the week 52 evaluation.
Subject has an active infection or history of infections.
Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the Investigator to be clinically significant and uncontrolled.
Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

478

Study ID:

NCT02029495

Recruitment Status:

Terminated

Sponsor:

Bausch Health Americas, Inc.

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There are 151 Locations for this study

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Huntsville Alabama, 35801, United States
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Tuscaloosa Alabama, 35406, United States
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Peoria Arizona, 85381, United States
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Scottsdale Arizona, 85258, United States
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Los Angeles California, 90095, United States
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Mather California, 95655, United States
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Murrieta California, 92563, United States
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Palm Desert California, 92260, United States
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Tustin California, 92780, United States
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Upland California, 91786, United States
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Jupiter Florida, 33458, United States
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Tamarac Florida, 33321, United States
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Tampa Florida, 33613, United States
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Gainesville Georgia, 30501, United States
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Meridian Idaho, 83642, United States
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Springfield Illinois, 62703, United States
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Bowling Green Kentucky, 42101, United States
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Somerset Kentucky, 42503, United States
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Frederick Maryland, 21702, United States
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Wheaton Maryland, 20902, United States
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Worcester Massachusetts, 01605, United States
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Lansing Michigan, 48910, United States
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Eagan Minnesota, 55121, United States
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Omaha Nebraska, 68114, United States
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Clifton New Jersey, 07012, United States
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Great Neck New York, 11021, United States
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Lake Success New York, 11042, United States
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New York New York, 10016, United States
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Plainview New York, 11803, United States
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Asheville North Carolina, 28803, United States
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Bend Oregon, 97701, United States
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Portland Oregon, 97239, United States
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Duncansville Pennsylvania, 16635, United States
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Charleston South Carolina, 29406, United States
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Hixson Tennessee, 37343, United States
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Austin Texas, 78731, United States
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Houston Texas, 77074, United States
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San Antonio Texas, 78232, United States
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Danville Virginia, 24541, United States
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Seattle Washington, 98104, United States
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Beckley West Virginia, 25801, United States
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Bridgeport West Virginia, 26330, United States
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Glendale Wisconsin, 53217, United States
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Hasselt , 3500, Belgium
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Leuven , 3000, Belgium
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Plovdiv , 4002, Bulgaria
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Plovdiv , 4003, Bulgaria
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Sofia , 1612, Bulgaria
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Sofia , 1709, Bulgaria
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Varna , 9010, Bulgaria
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Calgary Alberta, T2G 1, Canada
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Calgary Alberta, T3A 2, Canada
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Toronto Ontario, M5T 2, Canada
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Waterloo Ontario, N2J 1, Canada
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Trois-Rivieres Quebec, G8Z 1, Canada
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Quebec , G1V 3, Canada
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Brno , 611 4, Czech Republic
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Brno , 638 0, Czech Republic
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Ceske Budejovice , 370 0, Czech Republic
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Ostrava-Trebovice , 722 0, Czech Republic
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Pardubice , 530 0, Czech Republic
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Praha 2 , 128 5, Czech Republic
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Uherske Hradiste , 686 0, Czech Republic
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Pärnu , 80010, Estonia
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Tallinn , 10117, Estonia
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Cahors Cedex , 46005, France
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Orleans cedex 2 , 45067, France
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Rennes cedex 2 , 35203, France
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Saint-Etienne Cedex 2 , 42055, France
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Toulouse Cedex 9 , 31059, France
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Tours Cedex 1 , 37044, France
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Athens , 11527, Greece
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Athens , 12462, Greece
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Athens , 16121, Greece
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Athens , 16673, Greece
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Heraklion , 71110, Greece
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Thessaloniki , 56429, Greece
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Budapest , 1036, Hungary
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Budapest , 1062, Hungary
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Debrecen , 4032, Hungary
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Esztergom , 2500, Hungary
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Nyiregyhaza , 4400, Hungary
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Szekesfehervar , 8000, Hungary
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Szolnok , 5000, Hungary
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Firenze , 50134, Italy
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Milano , 20122, Italy
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Pavia , 27100, Italy
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Roma (RM) , 00133, Italy
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Roma , 00152, Italy
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Rome , 00144, Italy
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Verona , 37126, Italy
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Mexicali Baja California Norte, 21100, Mexico
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Leon Guanajuato, 37520, Mexico
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Guadalajara Jalisco, 44160, Mexico
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Guadalajara Jalisco, 44620, Mexico
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Guadalajara Jalisco, 44650, Mexico
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Ciudad Obregon Sonora, 85000, Mexico
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Merida Yucatán, 97133, Mexico
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Chihuahua , 31000, Mexico
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Distrito Federal , 03100, Mexico
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Gdansk , 80-95, Poland
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Gdynia , 81-38, Poland
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Katowice , 40-04, Poland
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Lodz , 90-24, Poland
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Lodz , 90-43, Poland
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Lublin , 20-60, Poland
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Poznan , 61-11, 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 , 02-11, Poland
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Warszawa , 02-65, 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 , 51-31, Poland
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Ekaterinburg , 62010, Russian Federation
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Moscow , 11552, Russian Federation
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Moscow , 12747, Russian Federation
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Nizhniy Novgorod , 60312, Russian Federation
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Nizhny Novgorod , 60300, Russian Federation
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Novosibirsk , 63009, Russian Federation
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Saint-Petersburg , 19006, Russian Federation
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Saratov , 41001, Russian Federation
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Yaroslavl , 15006, Russian Federation
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Banska Bystrica , 974 0, Slovakia
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Lucenec , 984 0, Slovakia
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Rimavska Sobota , 979 0, Slovakia
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Zilina , 01001, Slovakia
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Cordoba Andalucía, 14004, Spain
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Granada Andalucía, 18014, Spain
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Sevilla Andalucía, 41009, Spain
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Barcelona Cataluña, 08036, Spain
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Barcelona Cataluña, 08041, Spain
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Hospitalet de Llobregat Cataluña, 08907, Spain
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Sabadell Cataluña, 08208, Spain
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La Vila-Joiosa Comunidad Valenciana, 03570, Spain
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Merida Extremadura, 06800, Spain
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A Coruña Galicia, 15006, Spain
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Madrid , 28007, Spain
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Madrid , 28031, Spain
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Basel , 4031, Switzerland
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Geneva 14 , 1211, Switzerland
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Lausanne , 1011, Switzerland
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Zurich , 8091, Switzerland
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Birmingham , B15 2, United Kingdom
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Glasgow , G31 2, United Kingdom
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Hull , HU3 2, United Kingdom
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Leeds , LS7 4, United Kingdom
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London , E11 1, United Kingdom
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London , SE1 9, United Kingdom
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Manchester , M13 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

478

Study ID:

NCT02029495

Recruitment Status:

Terminated

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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