Efalizumab for Eczema

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: Genentech, Inc.
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement

• Investigator Global Assessment (IGA) score of "moderate" or worse

• In general good health with well-controlled medical problems

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.

• If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.

• Normal platelet count

Exclusion Criteria:

• Patients with known hypersensitivity to efalizumab or any of its components

• Pregnancy or lactation

• Patients receiving immunosuppressive agents

• Prior enrollment in the study

• Participation in another simultaneous medical investigation or trial

• IGA score of "mild," "almost clear" or "clear"

• Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week

• Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy.

• Ongoing, active, serious infection

• History of malignancy (except excised basal or squamous cell carcinoma of the skin)