Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percent of subjects achieving "clear" to "almost clear" on the Investigator Global Assessment [IGA] (success is achieved if 2 of 10 patients achieve "clear" or "almost clear" at any point in the study)
研究概览
简要总结
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).
详细描述
The study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. Biologic plausibility rests on similarities in pathophysiology of the two conditions. The drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. The subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. Efalizumab is not being compared to placebo or other drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Percent of subjects achieving "clear" to "almost clear" on the Investigator Global Assessment [IGA] (success is achieved if 2 of 10 patients achieve "clear" or "almost clear" at any point in the study)
次要结局
- Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA
- Percent improvement from baseline on the EASI (eczema area and severity index)
- Photography (quarter-body views, front and back)
- Pruritus improvement from baseline (rated on a scale of 1 to 10)