A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
研究概览
简要总结
This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have 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
- •patients with moderate to severe plaque type psoriasis for at least 6 months before randomization
- •patients eligible for systemic therapy with inadequately controlled psoriasis
排除标准
- •forms of sporiasis other than plaque type psoriasis
- •previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457 300 mg
patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
干预措施: AIN457 300 mg (Drug)
Ustekinumab
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
干预措施: ustekinumab 45/90 mg (Drug)
Ustekinumab
patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
干预措施: placebo secukinumab (Drug)
结局指标
主要结局
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16
时间窗: Week 16
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16
次要结局
- Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52(Week 52)
- Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4(Week 4)