jRCT2031220499进行中（未招募）不适用
A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies
Novartis Pharma. K.K.0 个研究点目标入组 57 人开始时间: 2022年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
- 主要终点
- Time to first composite event (i.e., relapse (UAS7>=16)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Male and female, adult participants >=18 years of age.
- •Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
- •Willing and able to adhere to the study protocol and visit schedule.
排除标准
- •Significant bleeding risk or coagulation disorders.
- •History of gastrointestinal bleeding.
- •Requirement for anti-platelet medication.
- •Requirement for anticoagulant medication.
- •History or current hepatic disease.
- •Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
结局指标
主要结局
Time to first composite event (i.e., relapse (UAS7>=16)
时间窗: 24 weeks
The efficacy of remibrutinib in CSU participants with a UAS7<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo. (Epoch 1)
次要结局
未报告次要终点
研究者
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