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

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

sites

Novartis Investigational Site

Charleston, South Carolina 29407

from

Charleston, SC