First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:8/10/2018
Start Date:May 8, 2012
End Date:October 24, 2016

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

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI
and IGA response rates versus placebo in subjects with 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. Other protocol-defined inclusion/exclusion
criteria may apply
We found this trial at
19
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Newnan, Georgia 30263
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Atlanta, Georgia 30322
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Austin, Texas 78759
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Birmingham, Alabama 35209
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Boston, Massachusetts 02118
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Boston, MA
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Bryan, Texas 77802
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Bryan, TX
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Charleston, South Carolina 29407
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Charleston, SC
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Fridley, Minnesota 55432
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Fridley, MN
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Glendale, Arizona 85308
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Glendale, AZ
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Goodlettsville, Tennessee 37072
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Goodlettsville, TN
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Hamilton, Ontario
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Hamilton,
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Houston, Texas 77030
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Houston, TX
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Lake Oswego, Oregon 97035
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Lake Oswego, OR
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Los Angeles, California 90095
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Los Angeles, CA
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Mobile, Alabama 36693
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Mobile, AL
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Omaha, Nebraska 68144
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Omaha, NE
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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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Skokie, Illinois 60077
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Skokie, IL
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