A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis

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

Details

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

Criteria

Inclusion Criteria:

• Body weight between 100kg and 150kg

• Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%

• Candidate for phototherapy or systemic therapy for Psoriasis

• CD4 + T lymphocyte counts > lower limit of normal

Exclusion Criteria:

• Clinically significant abnormal hematology values or blood chemistry values

• ALT or AST value of ≥ 3x the upper limit of normal

• Other types of Psoriasis

• Serious infection within 3 months prior to 1st dose of study drug

• Antibody positive for HIV

• History of malignancy

• History of severe allergic or anaphylactic reactions

• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease