A Phase 2 Multicenter, Randomized, Double-blind and Two-Stage Study to Evaluate the Efficacy and Safety of HSK47388 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of multiple-dose HSK47388 versus placebo 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of plaque psoriasis with a disease duration of at least 26 weeks before the first administration of the study intervention
- •Total Body Surface Area (BSA) involvement ≥ 10% at both screening and baseline visits
- •Psoriasis Area and Severity Index (PASI) total score ≥ 12 at both screening and baseline visits
- •Investigator Global Assessment (IGA) for plaque psoriasis total score ≥ 3 (moderate or severe disease) at both screening and baseline visits
- •Participants deemed appropriate candidates for systemic therapy for plaque psoriasis
排除标准
- •Non-plaque psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis)
- •Current drug-induced psoriasis
- •Current diagnosis, signs, or symptoms of severe, progressive, or uncontrolled disease involving the renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic systems
- •Known allergy, hypersensitivity, or intolerance to HSK47388。
- •A history of malignant tumor before screening;
- •Subjects deemed unsuitable for participation due to other factors as determined by the investigator
研究组 & 干预措施
HSK47388 matching placebo will be administered orally.
干预措施: HSK47388 (Drug)
HSK47388 dose 1 will be administered orally.
干预措施: HSK47388 (Drug)
HSK47388 dose 2 will be administered orally.
干预措施: HSK47388 (Drug)
HSK47388 dose 3 will be administered orally.
干预措施: HSK47388 (Drug)
结局指标
主要结局
HSK47388 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to week 16
时间窗: 16 weeks
Percentage of participants achieving PASI 75 response (\>=75% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system for assessing/grading psoriatic lesion severity and treatment response. It divides the body into 4 regions (head, trunk, upper extremities, lower extremities), with each region separately scored for erythema, induration, scaling (0-4 scale each) and involvement extent (0-6 scale). PASI yields a 0-72 numeric score, where higher scores mean more severe disease.
次要结局
- HSK47388 and placebo Group: Percentage of Participants Achieving an IGA Score of 0 or 1 and >=2 Grade Improvement From Baseline at Weeks 16(16 weeks)
- Change From Baseline in Body Surface Area (BSA) at Week 16(16 weeks)
- Number of Participants with Adverse Events (AEs)(20 weeks)
- HSK47388 and Placebo Group: Change From Baseline in Total DLQI Score at Week 16(16 weeks)