NCT07489885招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate to Severe Plaque Psoriasis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 20
- 主要终点
- Improvement in PASI-90
研究概览
简要总结
A Study looking at the safety and efficacy of D-2570 in Participants with Plaque Psoriasis
详细描述
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Participants with Moderate to Severe Plaque 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants with a diagnosis of plaque psoriasis with no significant flares of disease activity for at least 6 months before signing the informed consent
- •Participants have moderate to severe plaque psoriasis as defined by a total body surface area (BSA) ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥ 12 and a Physician's Global Assessment (PGA) score ≥
- •Within normal ranges of laboratory assessments
排除标准
- •Any comorbidities or past medical conditions as outlined in the protocol that would interfere with study assessments as deemed by the Investigator
研究组 & 干预措施
D-2570 low dose
Active Comparator
Low dose of D-2570
干预措施: D-2570 Tablet (Drug)
D-2570 High Dose
Active Comparator
medium dose level of D-2570
干预措施: D-2570 Tablet (Drug)
Placebo
Placebo Comparator
Placebo arm
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
Improvement in PASI-90
时间窗: Assessment completed after 12 weeks of treatment/placebo
Proportion of participants achieving at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
次要结局
未报告次要终点
研究者
研究点 (20)
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