NCT04774315进行中（未招募）4 期
Molecular Endotypes of Chronic Idiopathic Urticaria
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Responders
研究概览
简要总结
This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CIU as defined as frequent urticarial lesions for ≥ 6 weeks
- •Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily)
- •Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria
排除标准
- •Use of immunomodulatory drugs in the past 1 month prior to beginning the study
- •Use of systemic steroids in the past 1 month prior to beginning the study
- •Use of omalizumab in the past 3 months prior to beginning the study
- •Use of any investigational agent in the past 30 days
- •Untreated intercurrent illness
- •Severe Asthma
- •Primary diagnosis of flushing
研究组 & 干预措施
Omalizumab
Experimental
干预措施: Omalizumab (Drug)
结局指标
主要结局
Responders
时间窗: Week 16
The number of participants who meet the definition of "Responder" to omalizumab. "Responders" are defined as having a UAS7 of 6 or less after 16 weeks of treatment.
次要结局
- Baseline expression of innate immune markers(Baseline)
研究者
研究点 (1)
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