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

Astellas

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Biological: alefacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00808223

0485-CL-0004

2008-005830-63 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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).

Enrollment

30 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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