Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- NAPSI
研究概览
简要总结
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.
详细描述
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. This is a single arm trial - all patients will receive the study drug. We will examine time to response and different methods of defining nail disease response.
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
Open Label
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI>20
- •Active skin psoriasis currently (no minimum PASI or BSA) or skin psoriasis in the past documented by a dermatologist
- •Age 18-85
排除标准
- •History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable)
- •Inflammatory bowel disease
- •Metal implants or other concerns for use of MRI
- •Active infection
- •Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening.
- •We will exclude patients with onychomyosis of the fingernails on clippings
研究组 & 干预措施
Open Label
Secukinumab
干预措施: Secukinumab Auto-Injector (Drug)
结局指标
主要结局
NAPSI
时间窗: Baseline to 24 Weeks
Nail Psoriasis Severity Index (NAPSI): NAPSI is the most comprehensive nail assessment used in clinical trials. The fingernail is divided into four quadrants. For each quadrant, 1 point is assigned for a nail matrix abnormality and 1 point for a nail bed abnormality allowing for a total of 8 points per nail. 0-80 total points possible with a higher score corresponding to a worse outcome.
次要结局
- PASI(Baseline to 24 Weeks)
- DLQI(Baseline to 24 Weeks)
- Physician Global Assessment of Nail Disease(Baseline to 24 Weeks)