Overview
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.
Eligibility
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