A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis

A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.

Inclusion Criteria:

• Japanese participants aged 6 to 17 years at screening
• Participants must have a weight of ≥ 15 kg
• Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening
• Has moderate to severe plaque psoriasis at screening and baseline as defined by:
• PASI score ≥ 12; and
• BSA ≥ 10; and
• sPGA ≥ 3 (moderate to severe)
• Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis
• Candidate for systemic therapy or phototherapy

Exclusion Criteria:

• Psoriasis flare or rebound within 4 weeks prior to screening
• Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments
• Other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
• Prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
• Guttate, erythrodermic, or pustular psoriasis at screening and baseline