4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:5/27/2018
Start Date:September 16, 2012
End Date:May 4, 2017

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A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307
(core studies). This extension study planned to collect up to four years of long-term safety,
tolerability and efficacy data of secukinumab in both the fixed interval regimen and the
retreatment at start of relapse regimen. All subjects who completed the full study treatment
period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to
participate in this extension study. In this extension study, the prefilled syringe (PFS)
liquid formulation of secukinumab was used.


Inclusion Criteria:

1. Subjects must be able to understand and communicate with the investigator and comply
with the requirements of the study and must give a written, signed and dated informed
consent before any study related activity is performed. Where relevant, a legal
representative will also sign the informed consent according to local laws and
regulations.

2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study
CAIN457A2307

3. Subjects expected to benefit from participation in the extension study, as assessed by
the subject and investigator

Exclusion Criteria:

1. A protocol deviation in the core studies which according to the investigator will
prevent the meaningful analysis of the extension study for the individual subject

2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last
use of prohibited treatments in the core study to first dose of study drug in this
extension study.

3. Subjects expected to be exposed to an undue safety risk if participating in the trial

4. Current severe progressive or uncontrolled disease which in the judgment of the
investigator renders the subject unsuitable for the trial

5. Plans for administration of live vaccines during the study period

6. 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).
We found this trial at
30
sites
Miami, Florida 33136
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Anderson, South Carolina 29621
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Atlanta, Georgia 30322
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Atlanta, GA
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Boston, Massachusetts 02118
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Boston, MA
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Champaign, Illinois 61820
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Dallas, Texas 75216
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Dallas, Texas 75216
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Fresno, California 93710
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Fridley, Minnesota 55432
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Goodlettsville, Tennessee 37072
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Greensboro, North Carolina 27401
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Greer, South Carolina 29651
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Greer, SC
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Henderson, Nevada 89014
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High Point, North Carolina 27262
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32216
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Jacksonville, FL
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Jacksonville, Florida 32216
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Las Vegas, Nevada 89135
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Overland Park, Kansas 66210
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Pasadena, California 91105
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Salt Lake City, Utah 84103
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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 Francisco, California 94121
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Skokie, Illinois 60077
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Skokie, IL
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South Miami, Florida 33143
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South Miami, FL
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Verona, New Jersey 07044
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Verona, NJ
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Wels,
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West Palm Beach, Florida 33407
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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