A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,114
- 试验地点
- 1
- 主要终点
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
研究概览
简要总结
Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque 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 must give a written, signed and dated informed consent
- •Chronic plaque-type psoriasis present for at least 6 months before randomization
- •Moderate to severe plaque psoriasis as defined at randomization by:
- •PASI score of ≥12 and
- •Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
- •IGA mod 2011 ≥3 (based on a scale of 0-4)
- •Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
- •Topical treatment (including topical corticosteroids) and/or
- •Phototherapy and/or
- •Previous systemic therapy
排除标准
- •Forms of psoriasis other than plaque psoriasis
- •Drug-induced psoriasis
- •Ongoing use of prohibited treatments
- •Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
- •Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab
Secukinumab
干预措施: Secukinumab (Drug)
Ustekinumab
Ustekinumab
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12
时间窗: Week 12
Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).
Participants With IGA Mod 2011 0 or 1 at Week 12
时间窗: Week 12
Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)
次要结局
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4(Week 4)
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52(Week 52)
- Participants With IGA Mod 2011 0 or 1 at 16 Weeks(Week 16)
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12(Week 12)
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16(Week 16)
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12(Week 12)
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16(Week 16)
- Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16(Week 16)