Status:
COMPLETED
Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Psoriasis
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00808223
Start Date
April 1 2009
End Date
February 1 2012
Last Update
December 12 2013
Active Locations (5)
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1
Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
2
Physicians Skin Care, PLLC
Louisville, Kentucky, United States, 40217
3
First Municipal Hospital for Active Treatment - Sofia
Sofia, Bulgaria, 1000
4
Skin and STD Clinical Centre
Riga, Latvia, 1001