Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Galderma R&D
- 入组人数
- 600
- 试验地点
- 141
- 主要终点
- Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6
研究概览
简要总结
The main aim of this study is to assess real-world effectiveness of nemolizumab in Prurigo nodularis (PN) as measured by investigator and patient reported outcome (PRO) in clinical practice at Month 6.
详细描述
This prospective, multicenter, non-interventional study (NIS) seeks to evaluate PN treatment with nemolizumab (Nemluvio®) in adults over an approximately 12 month period using physician assessments in routine clinical practice and PRO measures. Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice.
The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak pruritus (PP) numerical rating scale (NRS) and Sleep Disturbance (SD) NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely and no clinic visits will be required.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Participants who, according to the treating physician's decision and in line with the local package label, are newly initiated on nemolizumab (Nemluvio®) for the treatment of PN.
- •Participants greater than or equal to (>=) 18 years of age.
- •Participants who signed the written informed consent form (ICF).
排除标准
- •Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label;
- •Participants who received treatment with a drug under clinical development/ investigation within 3 months prior to baseline.
- •Participants who received nemolizumab previously.
- •Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires.
研究组 & 干预措施
Nemolizumab
Participants with moderate-to-severe PN who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.
结局指标
主要结局
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6
时间窗: At 6 month
The IGA-CPG stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the physician. In this scale, nodules, papules, plaques, and other PN lesions are defined as pruriginous lesions or chronic prurigo lesions. A single score will be determined by the physician as follows: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe). A higher score indicates severe chronic prurigo.
Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6
时间窗: At 6 month
The PP NRS is a single-question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.
次要结局
- Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) Up to Month 12(Up to 12 months)
- Prurigo Activity Score (PAS) Up to Month 12(Up to 12 months)
- Peak Pruritus Numerical Rating Scale (PP NRS) Up to Month 12(Up to 12 months)
- Sleep Disturbance Numerical Rating Scale (SD NRS) Up to Month 12(Up to 12 months)