JPRN-jRCT2031220499招募中3 期
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
Hirano Takamitsu0 个研究点目标入组 57 人开始时间: 2022年12月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 57
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
- >= 18age old 至 ot applicable（—）
- 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.
研究者
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