Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Inclusion Criteria:

1. Subjects must give a written, signed and dated informed consent.

2. Men or women at least 18 years of age at time of screening.

3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.

4. Moderate to severe psoriasis as defined at Baseline by:

   • PASI score of 12 or greater, and
   • IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
   • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

   • topical treatment and/or,
   • phototherapy and/or,
   • previous systemic therapy.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
2. Drug-induced psoriasis.
3. Ongoing use of prohibited treatments.
4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
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.