A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes of saSPI (s) at Week 16 Compared to Baseline
研究概览
简要总结
Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.
详细描述
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open label single-arm study; therefore treatment blinding was not necessary.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
- •patient candidates for systemic therapy.
- •informed consent.
排除标准
- •previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
- •recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).
研究组 & 干预措施
Secukinumab
Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Changes of saSPI (s) at Week 16 Compared to Baseline
时间窗: Week 0 (baseline) to 16 weeks
The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition
proSPI (s) at Week 16 Compared to Baseline
时间窗: Week 0 (baseline) to 16 weeks
The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.
次要结局
- DLQI (Dermatology Life Quality Index) Over Time(weeks 0, 16, 52)
- Correlation Between PASI and proSPI (s)(week 0, 16, 52)
- PASI (Psoriasis Area Severity Index) Score(week 0, 16, 52)
- Self-administered PASI (SA-PASI)(weeks 0, 16, 52)
- saSPI (s, p and i) Over Time(weeks 0, 16, 52)
- proSPI (s, p and i) Over Time(weeks 0, 16, 52)
- Psoriasis Symptom Diary (PSD) Score(weeks 0, 16, 52)
- Correlation Between proSPI (for Each Component: s, p and i) and DLQI(weeks 0, 16, 52)
- Correlation Between proSPI (for Components p and i) and PASI(Over time (from Week 0 to Week 52))