safety and pharmacokinetics (pk) of alefacept in adolescent subjects with moderate to severe psoriasis

Conditions: Psoriasis

Summary: to establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.

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).

Eligibility criteria:
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

Keywords: alefacept adolescent psoriasis