Efalizumab in the Treatment of Alopecia Totalis/Universalis in Young Adults, Phase II
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percentage re-growth of scalp hair loss
研究概览
简要总结
Determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and severe ophiasis variants.
详细描述
This is a Phase II trial (single-center, open-label, prospective study) where subjects with severe forms of alopecia areata, namely alopecia totalis, universalis, and severe ophiasis, will be treated with efalizumab (Raptiva), a humanized monoclonal anti-CD11a antibody that reversibly inhibits T cell activation and migration, weekly for 48 weeks. We will assess for effect on hair and body re-growth as well as record any serious adverse events such as serious infections, thrombocytopenia, development of malignancy, and severe arthralgias to monitor for safety outcome data. Subjects will have regular physical examinations and laboratory studies throughout the study, as well as telephone interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •clinical diagnosis of alopecia totalis, alopecia universalis, or severe ophiasis variant of alopecia areata.
- •18-40 years of age.
- •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.
排除标准
- •known hypersensitivity to efalizumab (Raptiva) or any of its components.
- •known liver disease, including active hepatitis
- •history of autoimmune diseases causing alopecia other than alopecia areata.
- •prior biologic therapy within 6 months prior to study initiation.
- •history of any malignancy within last ten years, except treated non-melanoma skin cancers.
- •any woman currently pregnant or lactating.
- •intake of systemic immunosuppressive agents, including oral corticosteroids, within 3 months prior to study initiation.
- •history of positive PPD and/or tuberculosis.
- •history of HIV/AIDS
- •prior enrollment in any efalizumab study
- •any condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- •participation in another simultaneous clinical trial involving investigational agents.
- •positive HIV screening test obtained at screening visit.
- •positive QuantiFERON-TB test obtained at screening visit.
- •positive hepatitis screen obtained at screening visit.
- •platelet count 150 x 10(9)/L at baseline visit.
- •presence of any abnormal laboratory value obtained at screening visit assessed as clinically significant by principal investigator.
研究组 & 干预措施
Treatment
Subjects receiving drug
干预措施: efalizumab (Drug)
结局指标
主要结局
Percentage re-growth of scalp hair loss
时间窗: 1 year
次要结局
- Body hair re-growth at 48 weeks(1 year)
- Quality of life questionnaire(48 weeks)
- Self-assessment (SA) and Static physician global assessment (SPGA)(1 year)
研究者
Dennis West
Professor in Dermatology and Pediatrics
Northwestern University