A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Chronic Pruritus of Unknown Origin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 主要终点
- Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM310 in subjects with chronic pruritus of unknown origin.
详细描述
The study consists of a Screening Period (up to 4 weeks), Treatment Period (16 weeks) and Safety Follow-up Period (8 weeks).
50 subjects who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All subjects will receive mometasone furoate nasal spray (MFNS) on a daily basis as a background treatment throughout the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •With chronic pruritus of unknown origin.
- •With the worst pruritus numerical rating scale (WI-NRS) ≥
- •Contraception.
排除标准
- •Heavy drinking in the 3 months prior to screening.
- •With severe hepatic and renal impairment.
- •Previous history of autosensitivity dermatitis.
- •Allergic to CM310/placebo.
- •Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
结局指标
主要结局
Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS)
时间窗: at week 16
Change from baseline in the worst itching numerical rating scale at week 16
次要结局
- Safety parameters(Baseline up to Week 24)