Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept
in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with
severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to <18 years will be
enrolled, of which at least 30 will be 6 years to <12 years old. It is expected that subjects
will be enrolled at approximately 70 study sites worldwide

The purpose of this study is to demonstrate superior efficacy of secukinumab versus placebo
at Week 12, based on both PASI 75 and IGA mod 2011 0 or 1 response rates in children and
adolescents aged 6 to less than 18 years with severe chronic plaque psoriasis who had
inadequate control of symptoms with topical treatment, or failed to respond to or tolerate
previous systemic treatment and/or UV therapy

The study will assess the long term safety and tolerability of secukinumab in this pediatric
age group and will describe the efficacy and safety of secukinumab compared to etanercept.
This study will provide efficacy and safety data to support the extension of label of
secukinumab to include children and adolescents (6 years to <18 years) with severe chronic
plaque psoriasis

Two age subgroups will be studied in a staggered approach within this clinical study: 12 to
less than 18 years of age, and 6 to less than 12 years of age . Enrolment of children aged 6
to less than 12 years will begin after a favorable recommendation by an independent external
Data Monitoring Committee (DMC) who will review data of approximately 80 adolescents.
Adolescents will continue to be recruited while the data from the first 80 subjects are being
collected and analyzed

Subjects will be randomized using a 1:1:1:1 ratio into one of the treatment arms: secukinumab
low dose, secukinumab high dose, etanercept or placebo. Subjects randomized to secukinumab
treatment arms (high dose and low dose) will receive dose based on the weight category (<25
kg, 25 to <50kg, ≥50 kg).

The study consists of 5 periods: screening (up to 4 weeks), induction (of 12 weeks),
maintenance (of 40 weeks), extension treatment epoch (open-label of 184 weeks) and post-
treatment follow-up epoch (of 16 weeks).

The primary objectiove of the study is to demonstrate the superiority of secukinumab (low and
high dose) in pediatric subjects with severe chronic plaque psoriasis with respect to both
PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12, compared to
placebo

Inclusion criteria:

- Must be 6 to less than 18 years of age at the time of randomization

- Plaque-type psoriasis history for at least 3 months.

Severe plaque-type psoriasis meeting all of the following three criteria:

- PASI score of 20 or greater,

- Investigator's Global Assessment (IGA) score of 4

- Total body surface area (BSA) affected of 10% or greater.

- Patient being regarded by the investigator to be a candidate for systemic therapy
because of:

1. inadequate control of symptoms with topical treatment, or

2. failure to respond to or tolerate previous systemic treatment and/or UV therapy

Exclusion criteria:

- Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
pustular, erythrodermic, guttate) at randomization.

- Current drug-induced psoriasis.

- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

- Underlying condition (including, but not limited to metabolic, hematologic, renal,
hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal)
which in the opinion of the investigator significantly immunocompromises the subject
and/or places the subject at unacceptable risk for receiving an immunomodulatory
therapy

- History of an ongoing, chronic or recurrent infectious disease, or evidence of
untreated tuberculosis.

- History of lymphoproliferative disease or history of malignancy of any organ system
within the past 5 years.

- Pregnant or nursing (lactating) women.

- Other protocol-defined inclusion/exclusion criteria may apply.