JPRN-jRCT2080224087已完成3 期
A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines
ovartis Pharma K.K.0 个研究点目标入组 90 人开始时间: 2018年10月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •*Diagnosis of chronic spontaneous urticaria for at least 6 months
- •*Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
排除标准
- •*History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes
- •*Clearly defined cause of chronic urticaria other than chronic spontaneous urticaria
- •*Evidence of parasitic infection
- •*Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results
- •*Prior exposure to ligelizumab or omalizumab
- •*Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.
- •Other protocol defined inclusion/exclusion may apply
研究者
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