NCT07130604招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- The percentage of subjects with at least 90% improvement in PASI
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.
详细描述
This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis, with a total of 390 subjects planned to be enrolled.
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
- Triple (Participant, Care Provider, 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
- •Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
- •Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
- •During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
- •Hematology, Blood chemistry and Urinalysis examination were basically normal.
排除标准
- •Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
- •Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
- •History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
- •Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
- •Other conditions that the investigator considers inappropriate for participation in the study.
研究组 & 干预措施
D-2570 group1
Experimental
干预措施: D-2570 (Drug)
D-2570 group2
Experimental
干预措施: D-2570 (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage of subjects with at least 90% improvement in PASI
时间窗: Day 1-Day 112
The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.
次要结局
- Percentage of subjects with a PGA(Day1-Day365)
- The percentage of subjects with at least 75% improvement in PASI(Day1-Day365)
- The percentage of subjects with at least 90% improvement in PASI(Day1-Day365)
- The percentage of subjects with at least 100% improvement in PASI(Day1-Day365)
- The percentage of subjects with improvement in PASI(Day1-Day365)
- Percentage of subjects with a PGA score of 0 or 1 and ≥2 points from baseline(Day1-Day365)
- Percentage of subjects with baseline ss-PGA score ≥3(Day 1-Day 112)
- Percentage of subjects with baseline PGA-F score ≥3(Day 1-Day 112)
- Percentage of subjects with baseline pp-PGA score ≥3(Day 1-Day 112)
- Percentage of subjects with baseline DLQI score ≥2(Day 1-Day 112)
- The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570(Day1-Day365)
- The main PK parameters#Area under the plasma concentration versus time curve-AUC(Day1-Day365)
- The main PK parameters-Vz/F (apparent volume of distribution)(Day1-Day365)
- The main PK parameters Half-life -t1/2(Day1-Day365)
- The main PK parameters-CL/F (apparent clearance)(Day1-Day365)
- Weight and height will be combined to report BMI in kg/m^2(Day1-Day365)
- Incidence and severity of AEs based on NCI CTCAE V5.0(Day1-Day365)
- Incidence and severity of TEAEs based on NCI CTCAE V5.0(Day1-Day365)
研究者
研究点 (1)
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