Psoriasis Clinical Trial

Study of Efficacy and Safety 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. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. 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:

Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least

1 psoriatic skin lesion. 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:

484

Study ID:

NCT02024646

Recruitment Status:

Completed

Sponsor:

Bausch Health Americas, Inc.

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There are 103 Locations for this study

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Research Site
Peoria Arizona, 85381, United States
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Little Rock Arkansas, 72205, United States
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Cypress California, 90630, United States
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Hemet California, 92543, United States
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Huntington Beach California, 92646, United States
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La Jolla California, 92037, United States
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Palm Desert California, 92260, United States
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Palo Alto California, 94304, United States
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Victorville California, 92395, United States
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Saint Petersburg Florida, 33705, United States
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Sarasota Florida, 34239, United States
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Tampa Florida, 33612, United States
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Tampa Florida, 33614, United States
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Chicago Illinois, 60611, United States
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Paducah Kentucky, 42003, United States
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Baton Rouge Louisiana, 70809, United States
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Wheaton Maryland, 20902, United States
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Boston Massachusetts, 02111, United States
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Battle Creek Michigan, 49017, United States
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Grand Rapids Michigan, 49546, United States
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Lansing Michigan, 48910, United States
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Saint Louis Missouri, 63141, United States
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Las Vegas Nevada, 89102, United States
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Rochester New York, 14642, United States
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Oklahoma City Oklahoma, 73103, United States
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Tulsa Oklahoma, 74104, United States
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Dallas Texas, 75231, United States
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Dallas Texas, 75246, United States
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Waco Texas, 76708, United States
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Chesapeake Virginia, 23320, United States
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Seattle Washington, 98104, United States
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Calgary Alberta, T3A 2, Canada
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Victoria British Columbia, V8V 3, Canada
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Winnipeg Manitoba, R3A 1, Canada
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St. John's Newfoundland and Labrador, A1A 5, Canada
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St. John's Newfoundland and Labrador, A1C 5, 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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Quebec , G1V 4, Canada
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Bordeaux Cedex , 33076, France
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Le Kremlin Bicetre , 94270, France
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Lille cedex , 59037, France
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Lyon Cédex 3 , 69437, France
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Nantes cedex 1 , 44093, France
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Paris Cedex 10 , 75475, France
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Paris , 75018, France
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Reims Cedex , 51092, France
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Frankfurt , 60528, Germany
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Hannover , 30625, Germany
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Hildesheim , 31134, Germany
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Leipzig , 04103, Germany
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Lübeck , 23538, Germany
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Athens , 11527, Greece
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Athens , 14561, Greece
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Athens , 16673, Greece
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Larissa , 41110, Greece
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Thessaloniki , 56429, Greece
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Budapest , 1023, Hungary
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Budapest , 1036, Hungary
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Eger , 3300, 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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Szombathely , 9700, Hungary
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Riga , 1001, Latvia
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Riga , 1002, Latvia
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Riga , 1003, Latvia
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Riga , 1005, Latvia
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Mexicali Baja California Norte, 21100, 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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Gdansk , 80-95, Poland
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Gdynia , 81-38, Poland
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Grodzisk Mazowiecki , 05-82, 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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Wroclaw , 53-65, Poland
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Chelyabinsk , 45407, Russian Federation
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Ekaterinburg , 62007, Russian Federation
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Kemerovo , 65009, Russian Federation
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Kursk , 30500, Russian Federation
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Moscow , 12528, Russian Federation
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Petrozavodsk , 18501, Russian Federation
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Saint-Petersburg , 19224, Russian Federation
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Saratov , 41001, Russian Federation
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Smolensk , 21402, Russian Federation
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Voronezh , 39406, Russian Federation

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

484

Study ID:

NCT02024646

Recruitment Status:

Completed

Sponsor:


Bausch Health Americas, Inc.

How clear is this clinincal trial information?

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