A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects 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
- 150
- 试验地点
- 1
- 主要终点
- Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
详细描述
Patients with moderate to severe plaque psoriasis will be randomized into 3 cohorts (dose level 1, dose level 2 and placebo). Approximately 150 subjects will be enrolled. This study includes an 16-week treatment Period, then a 4-week safety visit period.
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
- •Fully understand and voluntarily participate this trial, and sign the informed consent form;
- •Age≥18 years, regardless of gender;
- •Plaque psoriasis;
- •A candidate for systemic therapy;
- •Agree to use a highly effective method(s) of from the signing of the informed consent form to 3 months post-treatment.
排除标准
- •Can not discontinue the prohibited medications specified in the protocol before the first dose and throughout the entire study period;
- •Laboratory abnormalities with clinical significance;
- •Forms of psoriasis other than chronic plaque-type;
- •Presence of other dermatological or autoimmune diseases;
- •Presence of active infection requiring systemic therapy;
- •Has undergone or plans to undergo major surgery;
- •History of cardiovascular or cerebrovascular diseases;
- •History of suicide attempts or major psychiatric disorders;
- •History of malignant tumors;
- •History of gastrointestinal surgery or diseases that may have impact on the study;
- •History of drug abuse, illicit drug use, or alcohol abuse;
- •History of severe drug allergies;
- •Pregnant or lactating women;
- •Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
研究组 & 干预措施
HSK44459 dose level 1
HSK44459 dosage 1 oral administration
干预措施: HSK44459 dose level 1 (Drug)
HSK44459 dose level 2
HSK44459 dose level 2 oral administration
干预措施: HSK44459 dose level 2 (Drug)
Placebo control
placebo oral administration
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of subjects who have ≥75% reduction in PASI (PASI-75).
时间窗: 16 weeks
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 16.
次要结局
- Proportion of subjects achieving an IGA score of clear 0 or 1 with ≥2 point reduction from baseline.(2, 4, 8, 12 and 16 weeks)
- Proportion of subjects who have ≥75% reduction in PASI (PASI-75).(2, 4, 8 and 12 weeks)
- Proportion of subjects who have ≥50% reduction in PASI (PASI-50).(2, 4, 8, 12 and 16 weeks)
- Proportion of subjects who have ≥90% reduction in PASI (PASI-90).(2, 4, 8, 12 and 16 weeks)