NCT00504270已完成2 期
A Randomized, Placebo-controlled Dose-ranging Pilot Study to Assess the Effect on Clinical Response, and the Safety and Tolerability of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Adverse events (AEs), laboratory parameters, pharmacokinetics
研究概览
简要总结
This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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 (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
- •adult patients, 18-70 years of age;
- •medically stable, moderate to severe chronic plaque psoriasis.
排除标准
- •any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
- •confounding or concomitant condition or treatment.
研究组 & 干预措施
Placebo
Placebo Comparator
po daily
干预措施: Placebo (Drug)
RG3421 120mg
Experimental
120mg po daily
干预措施: RG3421 120mg (Drug)
RG3421 20mg
Experimental
20mg po daily
干预措施: RG3421 20mg (Drug)
结局指标
主要结局
Adverse events (AEs), laboratory parameters, pharmacokinetics
时间窗: Throughout study
次要结局
- Change from baseline in static physician global assessment (PGA) score, Psoriasis Area and Severity Index (PASI) and exploratory biomarkers(Throughout study)
研究者
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