Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Open-Label,Singel Center Study to Evaluate the Safety and Efficacy of an Intramuskcular 12 Week-Course of Alefacept in Patients With Atopic Dermatitis|
- primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Additional enppoints are the percentage of patients reaching a PGA of "clear" or "almost clear" and/or a reduction of EASI of>=50 or >=75% compared to baseline at any visit after baseline. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- the percentage of patients reaching a pruritus score of none or mild [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Several immunological endpoints [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Study Completion Date:||January 2007|
Atopic dermatitis is a common chronic eczematous skin disease,wich often begins early in infancy and runs a course of remissions and exacerbations. T-lymphocytes play a prominent role in this skin disease. they represent the majority of skin-infiltrating cells and patients suffering from AD also have increased levels of activated circulating T cells and increased levels of markers of lymphocyte activation such as L-selectin and IL-2R.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376129
|Bern, Switzerland, 3110|
|Principal Investigator:||Nikhil Yawalkar, Prof||Dermatological Clinic Berne|