A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 509
- 试验地点
- 2
- 主要终点
- The Mean Percent Improvement From Baseline in PASI Score at Week 12
研究概览
简要总结
This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.
详细描述
CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.
排除标准
- •Patients diagnosed with forms of psoriasis other than plaque-type.
- •Patients previously received ustekinumab or a biosimilar of ustekinumab.
- •Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.
结局指标
主要结局
The Mean Percent Improvement From Baseline in PASI Score at Week 12
时间窗: From baseline to Week 12
The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
次要结局
- The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12(Week 12)
- The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12(Week 12)
- The PASI Scores at Week 12(Week 12)
- The Mean Percent Improvement From Baseline in PASI Score Through Week 52(Through Week 52)
- The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52(Through Week 52)