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
- Registration Number
- NCT00674063
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 alefacept Dose regimen 1 2 alefacept Dose regimen 2
- Primary Outcome Measures
Name Time Method Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline 1 Week post treatment
- Secondary Outcome Measures
Name Time Method Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline 1 Week post treatment