A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension

Inclusion criteria

• Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
• Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
• CD4+ T lymphocyte counts at or above the lower limit of normal

Exclusion criteria

• Clinically significant abnormal hematology values or blood chemistry values
• AST or ALT ≥ 3x the upper limit of normal
• Other types of Psoriasis
• Serious infection within the 3 months prior to the first dose of study drug
• History of drug or alcohol abuse within the past 2 years
• Antibody positive for HIV
• History of malignancy
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
• Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
• Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
• Current treatment with any therapy for tuberculosis
• Previous exposure to Alefacept
• Nursing mothers, pregnant women, and women planning to become pregnant during the study