A Phase II Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IBI112 dose 1
Participants will receive IBI112 dose 1 subcutaneous injection(SC)
干预措施: IBI112 dose 1 (Drug)
IBI112 dose 4
Participants will receive IBI112 dose 4 subcutaneous injection(SC)
干预措施: IBI112 dose 4 (Drug)
IBI112 dose 2
Participants will receive IBI112 dose 2 subcutaneous injection(SC)
干预措施: IBI112 dose 2 (Drug)
IBI112 dose 3
Participants will receive IBI112 dose 3 subcutaneous injection(SC)
干预措施: IBI112 dose 3 (Drug)
Placebo
Participants will receive placebo subcutaneous injection(SC)
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
时间窗: Week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
次要结局
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52(Week 52)
- Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16(Week 16)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52(Week 52)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16(Week 16)
- Change from Baseline in Dermatology life quality index(DLQI) at week 16(Week 16)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52(Week 52)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16(Week 16)
- Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52(Week 52)
- Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16(Week 16)
- Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52(Week 52)
- Change from Baseline in Dermatology life quality index(DLQI) at week 52(Week 52)