Efficacy and Safety of 2 Secukinumab Regimens in 90 kg or Higher Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

A 52-week multicenter, randomized, double-blind, parallel-group trial in approximately 330
subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher
at time of randomization.

The study consists of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks),
treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).

Subjects will be randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg
every 2 weeks; Secukinumab 300 mg every 4 weeks.

In addition, subjects from the 300 mg every 4 weeks group who do not achieve PASI 90 response
at Week 16 will be randomized using a 1:1 ratio to either remain on secukinumab 300 mg every
4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of
treatment.

Key Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed. Where
relevant, a legal representative will also sign the informed study consent according
to local laws and regulations.

2. Subjects must be able to understand and communicate with the investigator and comply
with the requirements of the study.

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

4. Body weight of ≥ 90 kg at the time of randomization.

5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before
randomization.

6. Moderate to severe psoriasis as defined at randomization by:

- Psoriasis Area and Severity Index (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.

7. 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.

Key Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
guttate psoriasis) at screening or Randomization.

2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to
be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and /
or the use of tanning devices) during the course of the study will be considered not
eligible for this study since UV light exposure is prohibited. Note: administration of
live vaccines 6 weeks prior to Randomization or during the study period is also
prohibited.

3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly
targeting Interleukin-17 (IL-17) or the IL-17 receptor.

4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives
of enrollment, or within 4 weeks until the expected pharmacodynamic effect has
returned to baseline, whichever is longer; or longer if required by local regulations.

5. Pregnant or nursing (lactating) women

6. History of lymphoproliferative disease or any known malignancy or history of
malignancy of any organ system treated or untreated within the past 5 years,
regardless of whether there is evidence of local recurrence or metastases (except for
skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been
treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the
cervix or non-invasive malignant colon polyps that have been removed).

7. History of hypersensitivity to any of the study drug constituents.