Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis

Study Overview
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Brief Summary
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To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.

Detailed Description
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A planned interim analysis will be conducted to evaluate safety and pharmacokinetics following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of the first 6 subjects will occur to monitor exposure. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).

Official Title
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A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis [ISN 0485-CL-0004]

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: alefacept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area Subject is a candidate for systemic treatment or phototherapy Subject is in good health and alefacept is not contraindicated Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT, AST and prothrombin. Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose Subject meets medication washout requirements and agrees to follow medication restrictions during the study Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits Exclusion Criteria: Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis Subject has a known hypersensitivity to alefacept or any excipient of the study medication Subject has had a serious local infection or systemic infection within 12 weeks prior to the first dose of study drug Subject has a fever (body temperature ≥ 38°C [or > 37°C for sites in Latvia]) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug Subject is known to be positive for HIV antibodies Subject has a history of chronic serious infection including hepatic disease or has positive result to serology test for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immuno-globulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug Subject has had more than six herpes simplex virus (HSV) breakouts per year or is currently having an outbreak or has had an outbreak within the last 24 weeks Subject has a history of malignancy (other than non-melanoma skin cancers) Subject has a chronic condition which is not well controlled Subject is pregnant or nursing Subject has a history of severe allergic or anaphylactic reactions

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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. alefacept<br> | Biological: alefacept<br>* IM injection<br>* Other names: ASP0485;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets |  | 4 Weeks | 
| Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled) |  | 4 weeks | 

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