A Phase Ⅰb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of TLL-018 in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
详细描述
Successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to previous biologics use for psoriasis.
After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.
Clinical psoriasis area and severity index (PASI), Physician's Global Assessment (PGA), 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 75 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 plaque psoriasis for at least 6 months prior to Baseline;
- •Subjects with moderate to severe plaque psoriasis covering ≥10% BSA, with a PASI ≥12 and sPGA score ≥3 at Baseline;
- •Able and willing to give written informed consent.
排除标准
- •Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, etc.);
- •Current drug-induced psoriasis, e.g., a new onset of psoriasis or an exacerbation of psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs or lithium;
- •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 1
TLL018 tablets, 1piece,BID
干预措施: TLL018 tablets (Drug)
Cohort 2
TLL018 tablets, 2pieces, BID
干预措施: TLL018 tablets (Drug)
Cohort 3
TLL018 tablets, 3pieces, BID
干预措施: TLL018 tablets (Drug)
Cohort 4
TLL018 placeboes, 3pieces, BID
干预措施: TLL018 tablets (Drug)
结局指标
主要结局
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
时间窗: From day 1 to Weeks 12
Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
blood pressure from baseline
时间窗: From day 1 to Weeks 12
Change of blood pressure from baseline
adverse events (AEs) according to severity
时间窗: From day 1 to Weeks 12
Number of adverse events (AEs) according to severity
pulse rate from baseline
时间窗: From day 1 to Weeks 12
Change of pulse rate from baseline
respiratory rate from baseline
时间窗: From day 1 to Weeks 12
Change of respiratory rate from baseline
temperature from baseline
时间窗: From day 1 to Weeks 12
Change of oral temperature from baseline
clinical laboratory abnormalities compared to baseline
时间窗: From day 1 to Weeks 12
Number of participants with clinical laboratory abnormalities compared to 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 12 hours post-dose
Maximum observed plasma concentration (Cmax) of TLL018
ECG parameters from baseline
时间窗: From day 1 to Weeks 12
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
physical examination findings from baseline
时间窗: From day 1 to Weeks 12
Number of participants with changes in physical examination findings from baseline
次要结局
- PASI score decreased from baseline at week 4(Baseline to Week 4)
- PASI score decreased from baseline at week 8(Baseline to Week 8)
- PASI score decreased from baseline at week 12(Baseline to Week 12)
- (sPGA) 0/1 response at week 4(Baseline to Weeks 4)
- (sPGA) 0/1 response at week 8(Baseline to Weeks 8)
- (sPGA) 0/1 response at week 12(Baseline to Weeks 12)