EUCTR2017-004207-52-EE进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled phase 2b dose-finding study to investigate the efficacy and safety of ligelizumab (QGE031) in adolescent patients with Chronic Spontaneous Urticaria (CSU)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Parent or legal guardian’s written informed consent and child’s assent
- •- Male and female adolescent patients aged = 12 to <18 years at the time of screening
- •- CSU diagnosis = 6 months and presence of itch and hives for at least 6 consecutive weeks at any time prior to enrollment
- •- Diagnosis of CSU refractory to approved doses of H1-antihistamines at the time of randomization
- •- Other protocol-defined criteria may apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Clearly defined underlying etiology for chronic urticarias other than CSU
- •- Any other skin disease associated with chronic itching that might confound the study evaluations and results
- •- Previous exposure to omalizumab
- •- History of anaphylaxis
- •- Other protocol-defined criteria may apply
研究者
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