NCT07519577尚未招募2 期
An Open-Label, Single-Arm, Multicenter, Extension Study to Evaluate the Safety and Efficacy of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
This is an open-label, single-arm, multicenter, extension study to evaluate the safety and efficacy of CM512 in patients With Chronic Rhinosinusitis with Nasal Polyposis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in the clinical study of CM512 in patients with Chronic Rhinosinusitis with Nasal Polyposis (Study No. of CM512-102101) .
排除标准
- •Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
- •Administration of a live attenuated vaccine within 30 days prior to baseline or planning to receive one during the study period.
研究组 & 干预措施
CM512
Experimental
干预措施: CM512 (Biological)
结局指标
主要结局
Occurrence of adverse events
时间窗: Up to week 64
Incidences of adverse events
Occurrence of adverse events
时间窗: Up to week 60
Incidences of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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