A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12
研究概览
简要总结
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type 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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
secukinumab 150 mg
Drug
干预措施: secukinumab 150 mg (Drug)
secukinumab 300 mg
Drug
干预措施: secukinumab 300 mg (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12
时间窗: 12 weeks
The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.
时间窗: 12 weeks
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
次要结局
- Percentage of Subjects With Successful Self Administration of Study Drug at Week 1(Week 1)
- Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)(Week 52)
- Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)(Week 52)
- Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)(Baseline and week 12)
- Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12(Week 12)
- Number of Subjects With Potential Use Related Hazards at Week 1(Week 1)
- Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48(Baseline, week 48)
- Absolute Change From Baseline for PASI Score at Week 12, (Induction)(Week 12)
- Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation(Week 12)
- Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)(Week 52)
- Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)(Week 12)
- Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)(Week 52)
- Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)(Week 52)
- Change From Baseline in EQ-5D at Week 12 (Induction)(Week 12)
- Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)(Baseline and week 52)
- Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52(Week 172)
- Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)(Week 172)
- Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)(Week 172)
- Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)(Week 12)
- Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity(Baseline and at Week 12, 24, 52, 100, 148, and 196, 204)
- Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)(Week 52)