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

Astellas

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: alefacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674063

C-738

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

1

Experimental group

Description:

Dose regimen 1

Treatment:

Drug: alefacept

2

Experimental group

Description:

Dose regimen 2

Treatment:

Drug: alefacept