Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Exclusion Criteria

• •Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
• •Pregnant or breast feeding.
• •Have failed more than 3 systemic agents for treatment of psoriasis.
• •History of allergy to any component of the investigational product (IP), including human immunoglobulin (Ig) proteins or allergy to etanercept.
• •Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
• •Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, Clostridium difficile).
• •Have a history of, or ongoing, chronic or recurrent infectious disease
• •Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before first administration of IP, or through Week 20 during the study.
• •Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
• •History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
• •Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• •Malignancy or history of malignancy, except for treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia \[CIN\] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
• •Psoriasis flare or rebound within 4 weeks prior to Screening.
• •Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis within 4 weeks prior to randomization
• •Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
• •Any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
• •Prior treatment with apremilast or etanercept.