Efalizumab for Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Raptiva


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age >= 18 years If a female of child bearing potential, a negative pregnancy test and commitment to birth control for the duration of the study are necessary. Diagnosis of atopic dermatitis using the Hanifin-Rajka criteria Disease severity of Moderate or Severe on the Rajka-Langeland Severity Score Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, ultraviolet light or other immunosuppressant. Specifically, patients are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies. Patients must meet the following washout requirements: Pre-Study and Concomitant Washout Period Restriction (Baseline Therapy Restrictions Prior to Study Thru End of Study) Investigational Drugs 4 Weeks Disallowed Light Treatments 4 Weeks Disallowed Systemic corticosteroid used 4 Weeks Disallowed for atopic dermatitis flare Topical tacrolimus or 2 Weeks Disallowed pimecrolimus Topical corticosteroids Must be on stable Allowed at stable doses dose for 2 weeks (Triamcinolone ointment 0.1% only) Any systemic 4 Weeks Disallowed immunosuppressive medication Topical and systemic antibiotics Cannot be on Allowed if infection antibiotics at the develops start of study Exclusion Criteria: Patient's with known hypersensitivity to Raptiva (efalizumab) or any of its components Pregnant or lactating women Patients receiving immunosuppressive agents Prior enrollment in the study Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. Participation in another simultaneous medical investigation or trial Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome) Systemic corticosteroid-dependent asthma Active infection of any type at the time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raptiva Open Label<br>Raptiva administered by weekly subcutaneous injections. First dose of 0.7mg/kg. Subsequent doses will be of 1mg/kg SQ weekly. | Drug: Raptiva<br>* Open Label<br>* Other names: Efalizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis | The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline | EASI Score collected at 12 weeks following baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in EASI score | Total percent of patients reaching 50% improvement in EASI score | Assessed 12 weeks after baseline | 
| Improvement in IGA score | Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score | Assessed 12 weeks after baseline | 
| Subject's assessment of overall response | Subject's assessment of overall response | End of study | 
| Change in serum IgE level | Change in serum IgE Level | Serum IgE collected at 12 weeks following baseline | 
| Pruritis (0-10 VAS Scale) change | Pruritis (0-10 VAS Scale) change | VAS scale collected at 12 weeks following baseline | 
| Time to first response | Time to first response as defined by a decrease of 25% in EASI score | Assessed on Days 28,56, and 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Raptiva