A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistamines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine (H1-AH) at locally label approved doses, for a duration of 52 weeks of treatment with remibrutinib and a post-treatment follow-up period of up to 4 weeks.
详细描述
The study consisted of three periods, the total study duration is up to 60 weeks: screening period of up to 4 weeks, open-label treatment period of 52 weeks (remibrutinib 25 mg b.i.d.), and a treatment free follow-up period of 4 weeks.
It was planned to include approximately 70 patients in the study; 71 patients were enrolled and included in the analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LOU064 25 mg b.i.d.
Patients were treated with remibrutinib 25 mg bis in die/twice a day (b.i.d.). LOU064 open-label treatment taken orally for 52 weeks.
干预措施: LOU064 (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: Baseline up to 30 days after last dose of study medication, assessed up to approximately 56 weeks
An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 30 days after the last study treatment.
次要结局
- Mean Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12(Baseline, Week 12)
- Number of Participants Who Achieved Disease Activity Control (UAS7 =< 6) at Week 12(Week 12)
- Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12(Week 12)
- Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12(Baseline, Week 12)
- Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12(Baseline, Week 12)
- Number of Participants Who Achieved Early Onset of Disease Activity Control (UAS7 =< 6) at Week 2(Week 2)
- Number of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0-1 at Week 12(Week 12)
- Mean Cumulative Number of Weeks With Disease Activity Control (UAS7 =< 6) up to Week 12(Up to Week 12)
- Mean Cumulative Number of Angioedema Occurrence-free Weeks (AAS7 = 0 Response) up to Week 12(Up to Week 12)