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

Study Overview
=================
Brief 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

Detailed Description
-----------------
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

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: alefacept
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Course A1<br> | Drug: alefacept<br>* Intramuscular (IM)<br>* Other names: ASP0485;|
| Placebo Comparator: Course A2<br> | Drug: placebo<br>* Intramuscular (IM)<br>|
| Experimental: Course B<br>Open label extension | Drug: alefacept<br>* Intramuscular (IM)<br>* Other names: ASP0485;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50 |  | 14 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving a PASI score of ≥ 50 any time during study |  | Throughout study | 
| Proportion of patients achieving a PASI score of ≥ 75 |  | 14 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Plaque Psoriasis, Alefacept