Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety, tolerability, and efficacy of Alefacept in patient with moderate to severe atopic dermatitis who could not be adequately controlled with topical therapies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Alefacept

Criteria

Inclusion Criteria:

• Signed Informed Consent Form(s)

• Age of l8 years or older

• A diagnosis of atopic dermatitis as determined by the diagnostic criteria for atopic dermatitis

• Disease severity of 3 or 4 (moderate or severe) as assessed by PGA rating (0-4 scale)

• Be a candidate for systemic therapy who cannot be adequately controlled (ie have a PGA assessment of 3 014) with topical therapies (Le., medium-to high-potency topical corticosteroids, tacrolimus, or pimecrolimus).

• For female subjects of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 3 months after the last dose of Alefacept

• Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other ultraviolet (UV) light sources during the study

Exclusion Criteria

• History of hypersensitivity to alefacept or any of its components

• History of illegal drug or alcohol abuse

• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection

• History of eczema herpeticum within the 30 days prior to screening

• History of opportunistic infections (e.g., systemic fungal infections, parasites)

• History of hepatitis B or C virus

• History of active tuberculosis (TB) or currently undergoing treatment for TB.

• Presence of history of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled in the study

• Pregnant or lactating women

• Diagnosis of hepatic cirrhosis, regardless of cause or severity

• Hospital admission for cardiovascular or pulmonary disease within the year prior to screening, including hospitalization for asthma exacerbations

• Subjects admitted to the hospital for chest pain that was subsequently determined to be non-cardiac in origin may be enrolled

• History of clinically significant anemia

• WBC count <4000/pL or> 14,000/pL

• Use of experimental drugs or treatments within 30 days or 5 half-lives, whichever is longer, prior to the first dose of alefacept

• Use of a live virus or live bacteria vaccine in the 14 days prior to be the first dose of alefacept

• Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug or would significantly interfere with the subject's ability to comply with the provisions of this protocol

• Any subject whose baseline atopic dermatitis PGA rating has changed to 0, 1, or 2 (clear, almost clear, or mild) from a screening rating of 3,4, or 5 (moderate, severe, or very severe)

Exclusion Criteria:

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