A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response 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 moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.
详细描述
This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.
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
- •Eligible for phototherapy or systemic therapy
- •Plaque covering ≥ 10% of BSA
- •PASI ≥ 12, sPGA ≥3
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
- •History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy
- •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 tablets 5mg (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 tablets 1mg (Drug)
HS-10374 Dose 2
干预措施: HS-10374 tablets 5mg (Drug)
Placebo
干预措施: HS-10374-matched placebo tablets (Drug)
HS-10374 Dose 1
干预措施: HS-10374 tablets 1mg (Drug)
结局指标
主要结局
Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12
时间窗: Baseline to Week 12
Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.
次要结局
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation(Baseline to Week 16)
- PASI 50 response rates at specified time points(Baseline to Week 16)
- Change from baseline in PASI scores at specified time points(Baseline to Week 16)
- Number of participants with abnormalities of physical examination(Baseline to Week 16)
- Incidence of clinically significant changes in electrocardiogram (ECG)(Baseline to Week 16)
- PASI 90 response rates at specified time points(Baseline to Week 16)
- Ctrough(Baseline to Week 12)
- Number of participants with clinical laboratory abnormalities(Baseline to Week 16)
- Number of participants with abnormalities of vital signs(Baseline to Week 16)
- Proportion of patients with sPGA 0/1 at specified time points(Baseline to Week 16)
- PASI 100 response rates at specified time points(Baseline to Week 16)
- Change from baseline in DLQI scores at specified time points(Baseline to Week 16)
- Change from baseline in BSA at specified time points(Baseline to Week 16)
- PASI 75 response rates at specified time points(Baseline to Week 16)