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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Biogen
• Treatments: Alefacept

Criteria

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