A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,306
- 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: PASI 75 (Psoriasis Area and Severity Index) .
研究概览
简要总结
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have 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
- •Subjects with chronic, plaque-type psoriasis for at least 6 months
- •Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
- •Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)
排除标准
- •Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
- •Drug induced psoriasis
- •Use of other psoriasis treatments during the study
- •Prior use of etanercept
- •Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor
- •Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
- •Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.
- •History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
- •Allergy to rubber or latex
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457 150mg
AIN457 150mg
干预措施: Placebo (Drug)
AIN457 150mg
AIN457 150mg
干预措施: secukinumab (AIN457) (Drug)
AIN457 300mg
AIN457 300mg
干预措施: Placebo (Drug)
AIN457 300mg
AIN457 300mg
干预措施: secukinumab (AIN457) (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
Etanercept
Etanercept
干预措施: Placebo (Drug)
Etanercept
Etanercept
干预措施: etanercept (Drug)
AIN457 150mg from Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
干预措施: Placebo (Drug)
AIN457 150mg from Placebo
Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase
干预措施: secukinumab (AIN457) (Drug)
AIN457 300mg from Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
干预措施: Placebo (Drug)
AIN457 300mg from Placebo
Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase
干预措施: secukinumab (AIN457) (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: PASI 75 (Psoriasis Area and Severity Index) .
时间窗: 12 wks
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
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
时间窗: 12 wks
The IGA mod 2011 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 mod 2011 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 mod 2011 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.
次要结局
- Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12(12 wks)
- Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12(12 wks)
- Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12(12 wks)
- Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)(52 wks)
- Number of Participants Developing Anti-secukinumab Antibodies(60 weeks)
- Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment(52 wks)
- Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo(baseline to week 12)
- Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept(baseline to week 12)