Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Rising i.v. (Stage 1) and s.c. (Stage 2) Doses of BI 655066 in Male and Female Patients With Moderate to Severe Psoriasis (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 9
- 主要终点
- Number of patients with good and satisfactory assessment of global tolerability by investigator
研究概览
简要总结
Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to severe psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
i.v. BI 655066
A subject to receive a single i.v. dose of BI 655066
干预措施: BI 655066 (very high i.v. dose) (Drug)
i.v. BI 655066
A subject to receive a single i.v. dose of BI 655066
干预措施: BI 655066 (low i.v. dose) (Drug)
i.v. BI 655066
A subject to receive a single i.v. dose of BI 655066
干预措施: BI 655066 (high medium i.v. dose) (Drug)
i.v. BI 655066
A subject to receive a single i.v. dose of BI 655066
干预措施: BI 655066 (very low i.v. dose) (Drug)
i.v. BI 655066
A subject to receive a single i.v. dose of BI 655066
干预措施: BI 655066 (high i.v. dose) (Drug)
i.v. BI 655066
A subject to receive a single i.v. dose of BI 655066
干预措施: BI 655066 (low medium i.v. dose) (Drug)
i.v. placebo
A subject to receive a single i.v. dose of placebo
干预措施: Placebo, i.v. (Drug)
s.c. BI 655066
A subject to receive a single s.c. dose of BI 655066
干预措施: BI 655066 (high s.c. dose) (Drug)
s.c. BI 655066
A subject to receive a single s.c. dose of BI 655066
干预措施: BI 655066 (low s.c. dose) (Drug)
s.c. placebo
A subject to receive a single s.c. dose of placebo
干预措施: Placebo, s.c. (Drug)
结局指标
主要结局
Number of patients with good and satisfactory assessment of global tolerability by investigator
时间窗: 24 weeks
Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator
时间窗: up to 1 week
Number of participants with adverse events
时间窗: up to 24 weeks
Number of participants with clinically relevant findings in vital signs
时间窗: up to 24 weeks
Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results
时间窗: up to 24 weeks
Number of participants with significant changes from baseline laboratory measurements
时间窗: up to 24 weeks
次要结局
- tmax (time from dosing to maximum measured concentration)(up to 24 weeks)
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(24 weeks)
- Psoriasis Area and Severity Index (percentage change from baseline)(up to 24 weeks)
- Psoriasis Area and Severity Index (absolute score)(up to 24 weeks)
- Percentage of participants with Static Physicians Global Assessment (clear and almost clear)(up to 24 weeks)
- Cmax (maximum measured concentration of the analyte in plasma)(up to 24 weeks)