NCT06278350已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical 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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Percentage of subjects with at least 75% improvement in PASI
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial 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
- 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 group 1
Experimental
D-2570 group 1
干预措施: D-2570 (Drug)
D-2570 group 2
Experimental
D-2570 group 2
干预措施: D-2570 (Drug)
D-2570 group 3
Experimental
D-2570 group 3
干预措施: D-2570 (Drug)
Placebo group
Placebo Comparator
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects with at least 75% improvement in PASI
时间窗: Day 1-Day 85
Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment
次要结局
- Percentage of subjects with at least 75% improvement in PASI(Day 1-Day 56)
- Percentage of subjects with at least 90% improvement in PASI(Day 1-Day 85)
- Percentage of subjects with 100% improvement in PASI(Day 1-Day 85)
- Percentage improvement in PASI(Day 1-Day 85)
- Percentage of subjects with a PGA(Day 1-Day 85)
- The main PK parameters ：Time to maximum measured plasma concentration（Tmax）(Day 1-Day 85)
- The main PK parameters ：Peak Plasma Concentration（Cmax)(Day 1-Day 85)
- The main PK parameters：Area under the plasma concentration versus time curve（AUC）(Day 1-Day 85)
- The main PK parameters： Mean Residence Time (MRT)(Day 1-Day 85)
- Weight and height will be combined to report BMI in kg/m^2(Day -28-Day 99)
- Incidence and severity of AEs based on NCI CTCAE V5.0(Day -28-Day 99)
- Incidence and severity of TEAEs based on NCI CTCAE V5.0(Day -28-Day 99)
- The main PK parameters：Vz/F (apparent volume of distribution)(Day 1-Day 85)
- The main PK parameters：CL/F (apparent clearance)(Day 1-Day 85)
- The main PK parameters： Half-life（t1/2）(Day 1-Day 85)
研究者
研究点 (1)
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