Efalizumab for Moderate to Severe Atopic Dermatitis
The purpose of this study is to determine if Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults|
- The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline as measured at 12 weeks.
- The following secondary efficacy outcome measures will be evaluated:
- Total percent of patients reaching 50% improvement in EASI score
- - Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score.
- - Subject's assessment of overall response
- - Change in serum IgE Level from baseline at 12 weeks
- - Pruritis (0-10 VAS Scale) change from baseline at 12 weeks.
- - Time to first response as defined by a decrease of 25% in EASI score on Days 28,56, and 84.
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||November 2005|
Atopic dermatitis is a common, highly pruritic, inflammatory skin disease that affects up to 17% of school-aged children. Most cases of childhood atopic dermatitis improve or resolve by adulthood. However, the majority of patients retain some features of atopic dermatitis and some continue to have severe disease that continues to adulthood. Moderate to severe atopic dermatitis cannot be adeuately controlled with topical agents. Consequently many patients are treated with systemic corticosteroids, cyclosporine, azathioprine, methotrexate, and other immunosuppressants that carry the risk of severe atopic dermatitis is greatly needed. The chronic use of current immunosuppressive agents is limited by cumulative end-organ toxicities. We propose inhibition of T cell trafficking to the skin with Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.