Studie zur Untersuchung von Secukinumab (Cosentyx) in der Behandlung der schweren Schuppenflechte bei Kindern/ Jugendlichen

Biological: Experimental : Secukinumab low dose;Biological: Experimental: Secukinumab high dose;Biological: Placebo Comparator: Secukinumab Placebo;Biological: Active Comparator: Etanercept

Gender: All
Maximum age: 17 Years
Minimum age: 6 Years

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.