Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in
this 6 month study to evaluate whether the response to intralesional alefacept injections
prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes
in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3
and an induration score greater than 1 will be identified on each patient. Each lesion will
receive only one intralesional alefacept injection during the first three weeks of the study
(1 lesion per week). Following a 2 week observation period, subjects will undergo a standard
12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity
Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept
treatments. An 8 week follow-up period will begin after the last dose of alefacept is
administered where safety and efficacy measures will continue to be monitored as outlined in
the study procedures. The hypothesis is that the response to intralesional alefacept
injections, whether it is positive or no benefit, will predict the clinical response to
intramuscular alefacept administration.