Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis

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.

Timeline

Start

2006-01

Primary completion

—

Completion

2007-01

Drugs

Indications