Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 2011
End Date:April 2013

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A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

This study will assess the safety and efficacy of secukinumab compared to placebo in patients
that have moderate to severe, chronic, plaque-type psoriasis.


Inclusion criteria:

- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

- Severity of psoriasis disease meeting all of the following three criteria:

- Psoriasis Area and Severity Index (PASI) score of 12 or greater,

- Investigator's Global Assessment (IGA) score of 3 or greater,

- Total body surface area (BSA) affected of 10% or greater.

- Inadequate control by prior use of topical treatment, phototherapy and/or systemic
therapy.

Exclusion criteria:

- Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
pustular, erythrodermic, guttate).

- Current drug-induced psoriasis.

- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

- Significant medical problems such as uncontrolled hypertension, congestive heart
failure or a condition that significantly immunocompromises the subject.

- Hematological abnormalities.

- History of an ongoing, chronic or recurrent infectious disease, or evidence of
untreated tuberculosis.

- History of lymphoproliferative disease or history of malignancy of any organ system
within the past 5 years.

- Pregnant or nursing (lactating) women.

- Subjects not willing to limit UV light exposure during the study Other
protocol-defined inclusion/exclusion criteria may apply.
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San Antonio, Texas 78207
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Ann Arbor, Michigan 48109
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Austin, Texas 78759
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Birmingham, Alabama 35209
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Boca Raton, Florida 33486
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Bryan, Texas 77802
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Caba, Buenos Aires
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Charleston, South Carolina 29407
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Colorado Springs, Colorado 80907
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Dallas, Texas 75216
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Duncansville, Pennsylvania 16635
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Evansville, Indiana 47713
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Houston, Texas 77030
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Nashville, Tennessee 37205
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
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Norfolk, Virginia 23507
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Oceanside, California 92056
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Omaha, Nebraska 68144
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Oregon City, Oregon 97045
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Pasadena, California 91105
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Philadelphia, Pennsylvania 19102
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Phoenix, Arizona 85012
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Portland, Oregon 97228
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Rochester, New York 14615
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Salt Lake City, Utah 84103
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San Diego, California 92123
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Snellville, Georgia 30078
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Topeka, Kansas 66606
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