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.
We found this trial at
30
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Antonio, TX
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Ann Arbor, Michigan 48109
1932
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Ann Arbor, MI
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Austin, Texas 78759
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Austin, TX
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Birmingham, Alabama 35209
1785
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Birmingham, AL
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Boca Raton, Florida 33486
2311
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Boca Raton, FL
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Bryan, Texas 77802
1282
mi
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Bryan, TX
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Caba, Buenos Aires
6113
mi
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Caba,
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Charleston, South Carolina 29407
2184
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Charleston, SC
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Colorado Springs, Colorado 80907
804
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Colorado Springs, CO
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Dallas, Texas 75216
1225
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Dallas, TX
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Duncansville, Pennsylvania 16635
2201
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Duncansville, PA
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Evansville, Indiana 47713
1715
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Evansville, IN
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Houston, Texas 77030
1357
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Houston, TX
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Los Angeles, California 90095
25
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Los Angeles, CA
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Louisville, Kentucky 40202
1812
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Louisville, KY
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Nashville, Tennessee 37205
1758
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Nashville, TN
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2435
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New York, NY
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Norfolk, Virginia 23507
2335
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Norfolk, VA
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Oceanside, California 92056
73
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Oceanside, CA
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Omaha, Nebraska 68144
1291
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Omaha, NE
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Oregon City, Oregon 97045
816
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Oregon City, OR
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Pasadena, California 91105
9
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Pasadena, CA
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Philadelphia, Pennsylvania 19102
2375
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Philadelphia, PA
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Phoenix, Arizona 85012
343
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Phoenix, AZ
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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Rochester, New York 14615
2244
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Rochester, NY
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Salt Lake City, Utah 84103
570
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Salt Lake City, UT
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San Diego, California 92123
100
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San Diego, CA
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Snellville, Georgia 30078
1938
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Snellville, GA
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Topeka, Kansas 66606
1280
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Topeka, KS
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