Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Inclusion Criteria:

Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
Subjects must have a weight of ≥ 20 kg
Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.

Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:

PASI score ≥ 12; and
Body surface area (BSA) ≥ 10%; and
sPGA ≥ 3 (moderate to severe)
Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
Candidate for systemic therapy or phototherapy

Exclusion Criteria:

Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
Psoriasis flare or rebound within 4 weeks prior to Screening
Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline

Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis

a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)

Exceptions*:

i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions

*Subjects should not use these topical treatments within 24 hours prior to the clinic visit.

b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).