NCT03183024已完成4 期
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody
Jonathan A. Bernstein, MD2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年9月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- change in urticarial activity score averaged over 7 days- no units
研究概览
简要总结
Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment
详细描述
Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single-blind
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines
排除标准
- •hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody
结局指标
主要结局
change in urticarial activity score averaged over 7 days- no units
时间窗: through study completion, up to 7 months
subject completed form
次要结局
- change in blood anti-TPO level (IU/L)(through study completion, up to 7 months)
- change in blood eotaxin level (pg/ml)(through study completion, up to 7 months)
- change in skin biopsy inflammatory cell counts(through study completion, up to 7 months)
- change in cytokine quantification in skin biopsy (units/mL)(through study completion, up to 7 months)
- change in blood anti-FCER1 level (kU/l)(through study completion, up to 7 months)
- change in Blood ECP level (ug/L)(through study completion, up to 7 months)
- change in RNA testing(through study completion, up to 7 months)
研究者
Jonathan A. Bernstein, MD
PI/ co-owner
Bernstein Clinical Research Center
研究点 (2)
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