A Multi-center, Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety for 16 Weeks in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
研究概览
简要总结
The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
- •Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L [2.0 mg/dL]) and hypertension at screening.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Secukinumab (AIN457) 300 mg
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
干预措施: Secukinumab (AIN457) (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
时间窗: Week 16
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 75 was defined as participants achieving \>= 75% improvement from baseline.
次要结局
- Mean Percent Change From Baseline in PASI Score(Week 4)
- Percentage of Participants Achieving PASI 50 or PASI 75(Week 4)
- Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response(Week 16)
- Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Week 16)
- Percentage of Participants Achieving DLQI 0 or 1(Week 16)