A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors 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
- 182
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
研究概览
简要总结
The purpose of this study was to demonstrate efficacy of autoinjector administered 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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects who were in placebo at Week 52 cannot continue in the extension treatment period
干预措施: Placebo (Drug)
Secukinumab 150 mg
After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period.
干预措施: Secukinumab 150mg (Drug)
Secukinumab 300 mg
After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.
干预措施: Secukinumab 300mg (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
时间窗: 12 weeks
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
次要结局
- Percentages of Subjects With Successful Self-administration of Study Drug at Week 1(Week 1)
- Percentage of Subjects With Possible Use-related Hazards(Week 1)
- Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12(Week 12)
- Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48(Absolute change from baseline at week 48)
- Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period(Week 12)
- Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)(Week 12 up to Week 52)
- Absolute Change From Baseline for PASI Score - Induction Period(Baseline, Week 12)
- Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)(Baseline, Week 52)
- Percentage of Participants in Each IGA Mod 2011 Category - Induction Period(Week 12)
- Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)(Week 52)
- Change From Baseline in EQ-5D up to Week 12 - Induction Period(Week 12)
- Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period(Week 52)
- Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period(Baseline, up to Week 12)
- Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period(Baseline, Week 52)
- Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period(Week 12)
- Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)(Week 52)
- Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)(Week 160)
- Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)(Week 160)
- Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)(Week 160)
- Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies(Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216)