A Multicenter,Randomized,Phase 3 Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 750
- 主要终点
- Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
研究概览
简要总结
The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese 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
- None
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
- •Age ≥18 years old, both male and female.
- •Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).
排除标准
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) .
- •Other inflammatory diseases.
- •Active autoimmune diseases.
- •Pregnant or lactating women.
研究组 & 干预措施
608 160 mg W0+80 mg Q2W
Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks.
干预措施: 608 Q2W (Drug)
608 160 mg Q4W
Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.
干预措施: 608 Q4W (Drug)
结局指标
主要结局
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
时间窗: At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
时间窗: At Week 12
次要结局
- Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)(At Week 12)
- Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100)(At Week 12)
- Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)(At Week 12)
- Adverse events (AE)(20 weeks)