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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
IM injection
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
Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
Time frame: 6 months
Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets
Time frame: 4 Weeks
Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)
Time frame: 4 weeks
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Department of Dermatology No.17, Children Clinical Hospital
Riga, Latvia