Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

Official Title
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An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Alefacept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR, Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728 Exclusion Criteria: Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study Clinically significant abnormal hematology values or history of an immunosuppressive disorder Serious local infection or systemic infection within 3 months prior to the first dose of alefacept A significant change in the subject's medical history from their previous alefacept study Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717 Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Alefacept<br>* intramuscular injection (IM)<br>* Other names: ASP0485;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring |  | Throughout treatment course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieved Almost Clear or Clear by Physicians' Global Assessment |  | Every 2 weeks throughout treamtent course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, alefacept, intramuscular