A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Apremilast 30 mg Twice Daily in Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO

Inclusion Criteria

• Chinese participants aged ≥18.
• Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0).
• Participant is a candidate for phototherapy and/or systemic therapy. Exclusion Criteria
• Psoriasis flare within 4 weeks of screening.
• Evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis.
• Prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
• Participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years.
• Active tuberculosis or a history of incompletely treated tuberculosis.
• History of human immunodeficiency virus (HIV) infection.
• Prior treatment with apremilast.
• Female participants of childbearing potential unwilling to use protocol specified method of contraception.
• Female participants who are breastfeeding or who plan to breastfeed.
• Female participants planning to become pregnant.