A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

Exclusion Criteria

• •The presence of any of the following will exclude a subject from enrollment:
• •Other than psoriasis, history of any clinically significant uncontrolled disease.
• •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
• •Hepatitis B surface antigen positive at screening
• •Anti-hepatitis C antibody positive at screening
• •Active tuberculosis (TB) or a history of incompletely treated TB
• •Clinically significant abnormality on 12-lead electrocardiogram (ECG) at 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 signing the informed consent form.
• •Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.
• •Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
• •Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
• •Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.
• •Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization
• •Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
• •Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
• •Prior treatment with apremilast
• •History of allergy or hypersensitivity to any components of the Investigational product.