NCT07326813招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 477
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
研究概览
简要总结
This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis.
Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period.
During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.
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
- •The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
- •Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
- •The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
- •At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
- •Hematology, Blood chemistry and Urinalysis examination were basically normal;
- •Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.
排除标准
- •Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
- •Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
- •A history of severe herpes zoster/simplex infection;
- •A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
- •Having language barriers, or being unwilling or unable to fully understand and cooperate;
- •Being pregnant or lactating women;
- •Other circumstances that the investigator deems unsuitable for the subject to participate in the study.
研究组 & 干预措施
Evaluate the efficacy of different doses of D-2570 compared with placebo
Experimental
干预措施: D-2570 Tablet (Drug)
Evaluate the efficacy of different doses of D-2570 compared with placebo
Experimental
干预措施: Placebo (Drug)
Evaluate the efficacy of different doses of D-2570 compared with BMS-98165
Active Comparator
干预措施: D-2570 Tablet (Drug)
Evaluate the efficacy of different doses of D-2570 compared with BMS-98165
Active Comparator
干预措施: BMS-986165 Tablet (Drug)
Evaluate the safety of D-2570 treatment at different dosages
Experimental
干预措施: D-2570 Tablet (Drug)
Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis
Experimental
干预措施: D-2570 Tablet (Drug)
结局指标
主要结局
To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis
时间窗: Treatment for 16 weeks after enrollment
Psoriasis Area and Severity Index (PASI)
次要结局
- To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis(Treatment for 16 weeks after enrollment)
- To evaluate the physical examination of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis(Through study completion, an average of 28 weeks)
- To evaluate the pharmacokinetic characteristics (PK) of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis(Day1, Day15, Day29, Day57, Day85, Day113)
- To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis(Through study completion, an average of 28 weeks)
研究者
研究点 (1)
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