A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.
详细描述
Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
- •18 ≤ Age ≤ 75 years old.
- •Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
排除标准
- •With drug-induced prurigo nodularis.
- •With clinically significant diseases.
- •With severe liver and kidney function damage at the screening.
- •With malignant tumors within the first 5 years before the screening.
- •Plan to undergo major surgical procedures during this study.
研究组 & 干预措施
Stapokibart
Stapokibart Injection, subcutaneous injection (SC)
干预措施: Stapokibart (Biological)
Placebo
subcutaneous injection (SC)
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.
时间窗: Up to week 24
The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours.
次要结局
未报告次要终点