A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 98
- 主要终点
- Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
研究概览
简要总结
This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).
详细描述
Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and safety at a dosage of 50mg subcutaneous (Sc) twice weekly.
Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.
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
- •Male or female adults
- •PsO diagnosis for 6 months
- •Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),
- •Body Surface Area (BSA) involved with PsO greater than or equal to 10%
- •Dermatology Life Quality Index (DQLI) greater than or equal to 10
- •Previously received phototherapy or systemic non-biologic therapy for PsO
排除标准
- •Forms of Psoriasis other than PsO
- •Drug induced Psoriasis
- •Positive QuantiFERON-tuberculosis (TB) Gold Test
- •Presence of significant comorbid conditions
- •Chemistry and hematology values outside protocol specified range
- •Major systemic infections
研究组 & 干预措施
Enbrel (etanercept)
Enbrel 50mg twice weekly times 12 weeks
干预措施: Etanercept (Drug)
CHS-0214
CHS-0214 50mg twice weekly times 12 weeks
干预措施: CHS-0214 (Drug)
结局指标
主要结局
Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
时间窗: 12-weeks
The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis. Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.
Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
时间窗: 12 Weeks
Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.
次要结局
- Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline(Weeks 4, 8, 12, 24, 36, and 48)
- Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5(4, 8, 12, 24, 36, and 48)
- Change in Subject's Global Assessment (SGA) of PsO(Weeks 4, 8, 12, 24, 36, and 48)
- Change in DLQI (Dermatology Life Quality Index)(Weeks 12, 24, and 48)
- Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)(Weeks 4, 8, 12, 24, 36, and 48)
- The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1(Weeks 4, 8, 12, 24, 36, and 48)
- The Proportion of Subjects With a Durability of Response at Week 48(Weeks 24, 36, and 48 when compared to baseline (Week 0).)
- Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)(Weeks 4, 8, 12, 24, 36, and 48)
- Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)(Weeks 12, 24, and 48)
- Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Weeks 12, 24, and 48)
- Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)(Weeks 12, 24, and 48)