Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:July 2013

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A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, 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 and
etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Inclusion Criteria:

- Subjects with chronic, plaque-type psoriasis for at least 6 months

- Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater
than 3, and greater than 10% body surface area

- Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or
systemic therapies)

Exclusion Criteria:

- Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic
and guttate psoriasis)

- Drug induced psoriasis

- Use of other psoriasis treatments during the study

- Prior use of etanercept

- Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the
IL-17 receptor

- Pregnant or lactating women; women who do not agree to use contraception during the
study and for 16 weeks after stopping treatment

- Significant medical problems such as uncontrolled high blood pressure, congestive
heart failure, etc.

- History of an ongoing, chronic or recurrent infection or evidence of tuberculosis

- Allergy to rubber or latex

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
13
sites
Phoenix, Arizona 85012
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Birmingham, Alabama 35209
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Birmingham, AL
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Caba, Buenos Aires
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Caba,
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Charleston, South Carolina 29407
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Charleston, SC
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High Point, North Carolina 27262
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High Point, NC
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Johnston, Rhode Island 02919
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Johnston, RI
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Kingsport, Tennessee 37660
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Kingsport, TN
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Norfolk, Virginia 23507
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Norfolk, VA
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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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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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San Diego, California 92123
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San Diego, CA
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Warren, Ohio 44483
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Warren, OH
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