Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in the Basophil Proteome
研究概览
简要总结
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.
详细描述
The purpose of this study is to evaluate for changes in the proteins produced in white blood cells (basophils) in patients with chronic hives who are treated with and respond to omalizumab.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic urticaria (hives) for more than 6 weeks.
- •No improvement with standard doses of antihistamines (loratadine 10 mg daily, desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or levocetirizine 5 mg daily)
排除标准
- •Taken any oral steroids for 1 month prior to beginning the study.
- •Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine, cyclosporine, methotrexate) for 1 month prior to beginning the study.
- •Physical urticaria as a primary diagnosis.
- •Known allergic precipitant of urticaria such as foods.
- •Urticarial Vasculitis.
- •Serum Immunoglobulin E (IgE) >700 IU/ml.
- •Women of childbearing potential not using contraception method(s), as well as women who are pregnant and/or breastfeeding.
- •Known sensitivity to omalizumab or this class of drug.
- •Use of any other investigational agent in the last 1 month.
- •Untreated intercurrent illness.
研究组 & 干预措施
Omalizumab
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
干预措施: Omalizumab (Drug)
结局指标
主要结局
Change in the Basophil Proteome
时间窗: Baseline through week 13
In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.
次要结局
- Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.(Baseline through week 13)