Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
Protocol Title: Open-label,single center study to evaluate the savety and efficacy of an
intramuscular 12 week-course of Alefacept in patients with atopic dermatitis.
Study Phase: II
Study Design: Open-label, single center Primary Study Objective: to determine the safety and
efficacy of one course of Alefasept when administered as a 15 mg intramuscular ( IM)
injektion to patients with atopic dermatitis
Secondary Study Objective: to investigate key immunological parameters involved in the
pathology of this common skin disease to interpret the clinical findings
Number of patients: 10
Study Population: Male and female patients, at least 18 years of age with atopic dermatitis,
aktive inflammation, a severity score of 6-9 according to Langeland and Rajika and an EASI of
>20
Treatment Groups: Alefacept will be administered as a 15 mg IM injection once a week for 12
weeks, followed by a 12-week follow-up period.