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

Completed · Phase 2

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID: NCT00808223
Run by: Astellas Pharma Inc
People needed: 30
Starts: 2009-04-01
Expected to finish: 2012-02-01
Last updated by the study team: 2013-12-12

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Pediatric and Adolescent Dermatology — San Diego, California, United States
Physicians Skin Care, PLLC — Louisville, Kentucky, United States
First Municipal Hospital for Active Treatment - Sofia — Sofia, Bulgaria
Skin and STD Clinical Centre — Riga, Latvia
Department of Dermatology No.17, Children Clinical Hospital — Riga, Latvia

Full record on ClinicalTrials.gov

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