Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- blood pressure from baseline
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.
详细描述
Successfully screened subjects will be randomized in a ratio of 1：1：1. After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.
Clinical Urticaria Activity Score (UAS), dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a diagnosis of moderate to severe Chronic Spontaneous Urticaria for at least 6 months prior to Baseline;
- •Subjects with moderate to severe Chronic Spontaneous Urticaria UAS7 score ≥16 at Baseline;
- •Able and willing to give written informed consent.
排除标准
- •Other types of Chronic Urticaria (such as Artificial urticaria, cold-contact urticaria, heat-contact urticaria etc);
- •Other disease with symptoms of urticaria or angioedema, e.g., Urticaria vasculitis, color Vegetarian urticaria, erythema multiforme;
- •History or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis;
- •Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.
研究组 & 干预措施
Cohort 3
TLL018 placeboes 3pieces, BID
干预措施: TLL018 tablets (Drug)
Cohort 1
TLL018 tablets 1piece,BID
干预措施: TLL018 tablets (Drug)
Cohort 2
TLL018 tablets 3pieces, BID
干预措施: TLL018 tablets (Drug)
结局指标
主要结局
blood pressure from baseline
时间窗: From day 1 to Weeks 4
Change of blood pressure from baseline
pulse rate from baseline
时间窗: From day 1 to Weeks 4
Change of pulse rate from baseline
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
时间窗: From day 1 to Weeks 4
Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
adverse events (AEs) according to severity
时间窗: From day 1 to Weeks 4
Number of adverse events (AEs) according to severity
respiratory rate from baseline
时间窗: From day 1 to Weeks 4
Change of respiratory rate from baseline
Cmax of TLL018
时间窗: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 8 hours post-dose
Maximum observed plasma concentration (Cmax) of TLL018
temperature from baseline
时间窗: From day 1 to Weeks 4
Change of oral temperature from baseline
ECG parameters from baseline
时间窗: From day 1 to Weeks 4
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
clinical laboratory abnormalities compared to baseline
时间窗: From day 1 to Weeks 4
Number of participants with clinical laboratory abnormalities compared to baseline
physical examination findings from baseline
时间窗: From day 1 to Weeks 4
Number of participants with changes in physical examination findings from baseline
次要结局
- treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs(From week 4 to Weeks 12)
- ECG parameters from baseline(From week 4 to Weeks 12)
- UAS7 score decreased from baseline at week 4(Baseline to Week 4)
- respiratory rate from baseline(From week 4 to Weeks 12)
- UAS7 score decreased from baseline at week 8(Time Frame: Baseline to Week 8)
- DLQI score decreased from baseline at week 4(Baseline to Weeks 4)
- blood pressure from baseline(From week 4 to Weeks 12)
- temperature from baseline(From week 4 to Weeks 12)
- UAS7 score decreased from baseline at week 12(Baseline to Week 12)
- DLQI score decreased from baseline at week 12(Baseline to Weeks 12)
- adverse events (AEs) according to severity(From week 4 to Weeks 12)
- pulse rate from baseline(From week 4 to Weeks 12)
- clinical laboratory abnormalities compared to baseline(From week 4 to Weeks 12)
- physical examination findings from baseline(From week 4 to Weeks 12)
- DLQI score decreased from baseline at week 8(Baseline to Weeks 8)