Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:June 19, 2012
End Date:June 26, 2017

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A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

This was an extension study of secukinumab prefilled syringes in subjects with moderate to
severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with
secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies
(e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III
studies) were eligible to join this extension study. This extension study was planned to
collect an additional 2 years of long-term efficacy, safety, and tolerability data of
secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in
subjects showing at least partial response to secukinumab and completing treatment period on
secukinumab in previous phase III studies. In this extension study, the prefilled syringe
(PFS) liquid formulation of secukinumab were used.


Key Inclusion Criteria:

Completed the full study treatment period of 52 weeks in preceding phase III studies, and
have been receiving secukinumab treatment during the maintenance phase of the preceding
phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of
the preceding phase III studies.

Written informed consent form.

Key Exclusion Criteria:

A protocol deviation in either of the preceding phase III studies which according to the
investigator prevented the meaningful analysis of the extension study for the individual
subject.

Ongoing use of prohibited psoriasis or non-psoriasis treatments.

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test (>10 mIU/mL).

Women of child-bearing potential, defined as all women physiologically capable of becoming
pregnant, unwilling to use effective contraception during the study and for 16 weeks after
stopping treatment.
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Houston, Texas 77030
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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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Caba, Buenos Aires
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Charleston, South Carolina 29407
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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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High Point, North Carolina 27262
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Indianapolis, Indiana 46202
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Johnston, Rhode Island 02919
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Kingsport, Tennessee 37660
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Louisville, Kentucky 40202
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Nashville, Tennessee 37205
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230 Park Avenue, 21st Floor
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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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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 Antonio, Texas 78207
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San Antonio, Texas 78207
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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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Warren, Ohio 44483
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