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.
We found this trial at
40
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Topeka, Kansas 66606
678
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Topeka, KS
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Ann Arbor, Michigan 48109
164
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Ann Arbor, MI
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Austin, Texas 78759
1065
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Austin, TX
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Birmingham, Alabama 35209
495
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Birmingham, AL
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Birmingham, Alabama 35209
495
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Birmingham, AL
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Caba, Buenos Aires
5386
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Caba,
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Charleston, South Carolina 29407
525
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Charleston, SC
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Charleston, South Carolina 29407
525
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Charleston, SC
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Colorado Springs, Colorado 80907
1162
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Dallas, Texas 75216
914
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Dallas, Texas 75216
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Duncansville, Pennsylvania 16635
244
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High Point, North Carolina 27262
321
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High Point, NC
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Houston, Texas 77030
995
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Houston, TX
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Indianapolis, Indiana 46202
167
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Indianapolis, IN
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Johnston, Rhode Island 02919
614
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Johnston, RI
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Kingsport, Tennessee 37660
237
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Kingsport, TN
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Los Angeles, California 90095
1982
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Los Angeles, CA
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Louisville, Kentucky 40202
188
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Louisville, KY
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Louisville, Kentucky 40202
188
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Louisville, KY
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Nashville, Tennessee 37205
339
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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...
481
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New York, NY
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Norfolk, Virginia 23507
421
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Norfolk, VA
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Oceanside, California 92056
1945
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Omaha, Nebraska 68144
691
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Oregon City, Oregon 97045
2024
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Oregon City, OR
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Pasadena, California 91105
1965
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Philadelphia, Pennsylvania 19102
416
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Philadelphia, PA
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Phoenix, Arizona 85012
1660
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Phoenix, Arizona 85012
1660
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2028
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Portland, OR
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2028
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Portland, OR
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Rochester, New York 14615
356
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Rochester, NY
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Salt Lake City, Utah 84103
1513
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Salt Lake City, UT
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1139
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San Antonio, TX
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1139
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San Diego, California 92123
1947
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San Diego, California 92123
1947
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Snellville, Georgia 30078
425
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Snellville, GA
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Warren, Ohio 44483
145
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Warren, OH
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