A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12
研究概览
简要总结
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.
详细描述
This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.
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
- Double (Participant, 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
- •Male or female subjects between the ages of 18-70 years
- •Diagnosis of plaque psoriasis for at least 6 months
- •sPGA score of 2-3, BSA 2-15%, PASI score 2-15
- •Subject must be inadequately controlled with, or intolerant of at least one topical therapy
排除标准
- •Diagnosis of non-plaque psoriasis or drug-induced psoriasis
- •Recent history of infection, history or risk of serious infection
- •Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
- •Any condition possibly affecting the PK process of the study drug
- •Evidence of other skin conditions that would interfere with the evaluation of psoriasis
- •History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
- •Prior exposure to TYK2 inhibitors
- •Have received the prohibited treatment during the protocol required washout period
- •Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
研究组 & 干预措施
HS-10374 Dose 1
干预措施: HS-10374 6mg tablets (Drug)
HS-10374 Dose 1
干预措施: HS-10374-matched placebo tablets (Drug)
HS-10374 Dose 2
干预措施: HS-10374 6mg tablets (Drug)
Placebo
干预措施: HS-10374-matched placebo tablets (Drug)
结局指标
主要结局
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12
时间窗: Baseline to Week 12
Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.
次要结局
- Number of participants with abnormalities of vital signs(Baseline to Week 16)
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation(Baseline to Week 16)
- Number of participants with clinical laboratory abnormalities(Baseline to Week 16)
- Incidence of clinically significant changes in electrocardiogram (ECG)(Baseline to Week 16)
- Number of participants with abnormalities of physical examination(Baseline to Week 16)
- Proportion of patients with sPGA 0/1 at specified time points(Baseline to Week 16)
- Proportion of patients achieving BSA 75 response at specified time points(Baseline to Week 16)
- Change from baseline in BSA at specified time points(Baseline to Week 16)
- Proportion of patients who achieved BSA ≤ 1% at specified time points(Baseline to Week 16)
- Change from baseline in PASI at specified time points(Baseline to Week 16)
- Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points(Baseline to Week 16)
- Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points(Baseline to Week 16)
- Change from baseline in DLQI scores at specified time points(Baseline to Week 16)