A Randomized, Double-blind, Placebo-controlled, Multicenter, Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Nail Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 41
- 主要终点
- Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment
研究概览
简要总结
This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.
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
- Double (Participant, Investigator)
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 moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%
- •Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy
排除标准
- •Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
- •Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
- •Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects
- •Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply
- •Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
- •Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
- •History of hypersensitivity to constituents of the study treatment
- •Other protocol-defined inclusion/exclusion criteria do apply
研究组 & 干预措施
Secukinumab (AIN457) 300 mg
Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.
干预措施: Secukinumab (Biological)
Placebo
Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.
干预措施: Placebo (Biological)
Secukinumab (AIN457) 150 mg
Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.
干预措施: Secukinumab (Biological)
结局指标
主要结局
Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment
时间窗: Baseline, 16 weeks
The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.
次要结局
- Percent Change From Baseline in NAPSI Score(baseline, 16 weeks, 132 weeks)
- Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132(16 weeks, 132 weeks)
- Number of Participants Who Develop Immunogenicity Against Secukinumab(Week 132)