NCT07362017招募中3 期
A Multicenter, Open Label Study to Investigate the Safety and Efficacy of Ponesimod in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)
研究概览
简要总结
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18-65 years, inclusive
- •BMI >18 and <40
- •Minimum affected BSA of 10%
- •PASI score ≥ 12
- •Diagnosed with moderate-to-severe plaque psoriasis
排除标准
- •Diagnosis of generalized erythrodermic, generalized pustular (von Zumbusch), guttate, or palmoplantar psoriasis
- •History of an allergic reaction or known and/or significant sensitivity to study drug
研究组 & 干预措施
Ponesimod
Experimental
Ponesimod
干预措施: Ponesimod (Drug)
结局指标
主要结局
Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)
时间窗: Through study completion, approximately 1 year
Safety will be assessed based on frequency of treatment-emergent adverse events and serious adverse events, and frequency of clinically notable abnormal vital signs, blood chemistry, hematology, urology, and ECGs
次要结局
未报告次要终点
研究者
研究点 (4)
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