An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,660
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16
研究概览
简要总结
Study of effects of secukinumab 300 mg s.c. on quality of life (QoL) in psoriasis in patients with or without prior exposure to systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Men or women aged at least 18 years at time of Screening.
- •Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
- •Other protocol defined inclusion criteria may apply. Please refer to the protocol.
排除标准
- •Forms of psoriasis other than moderate to severe plaque-type psoriasis, e.g. drug-induced psoriasis at Screening.
- •Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential unless they use effective contraception
研究组 & 干预措施
Secukinumab
All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16
时间窗: 16 weeks
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
次要结局
- Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52(52 weeks)
- Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52(52 weeks)
- Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52(Week 16, Week 52)
- Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52(Week 16, Week 52)
- Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52(Week 16, Week 52)
- Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52(Week 16 and Week 52)
- Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52(16 and 52 weeks)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52(16 and 52 weeks)
- Patient Benefit Index (PBI) at Week 16 and Week 52(Week 16 and Week 52)