NCT06171074尚未招募2 期
A Multicenter, Single Arm Phase II Clinical Study Evaluating the Efficacy of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS)
研究概览
简要总结
This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.
详细描述
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-
- •Understand the study and sign the Informed Consent Form voluntarily.
- •Take effective contraception measures throughout the study period.
排除标准
- •Used other investigational drugs.
- •Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM
- •Plan to participate in other studies during this clinical trial.
- •With malignant or benign tumors of the nasal cavity.
- •Other reasons the researcher believes that the subject is not suitable to participate in this study.
结局指标
主要结局
Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS)
时间窗: Up to week 12
The total score of nasal symptoms (TNSS) is the sum of four symptom scores: runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3 points.
次要结局
未报告次要终点
研究者
研究点 (1)
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