A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Nasal Congestion Score (NCS)
研究概览
简要总结
This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
详细描述
The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period and 28 weeks for open-label maintenance treatment) and Safety Follow-up Period (8 weeks).
180 patients 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 12 times at the double-blind treatment period and 14 times at the open-label treatment period. All patients will receive MFNS on a daily basis as a background treatment throughout the study.
Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts & percentage.
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
- •with chronic rhinosinusitis with nasal polyposis (CRSwNP).
- •Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
- •NCS score of 2 or 3 at screening period, and at least 2 at baseline.
- •Contraception.
排除标准
- •Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
- •Participated and any studies of CM
- •With malignant or benign tumor of nasal cavity.
- •Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
研究组 & 干预措施
CM310
CM310 300mg is given subcutaneously (SC) every two weeks
干预措施: Placebo (Biological)
Placebo
Placebo is given subcutaneously (SC) every two weeks
干预措施: CM310 (Biological)
结局指标
主要结局
Nasal Congestion Score (NCS)
时间窗: at week 24
Change from baseline in the Nasal Congestion Score (NCS) at week 24. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Nasal Polyps Score (NPS)
时间窗: at week 24
Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
次要结局
- Safety parameters(Baseline up to Week 60)
- Anti-drug antibodies (ADA)(Baseline up to Week 60)
- Pharmacokinetics (PK)(Baseline up to Week 60)
- Pharmacodynamics (PD)(Baseline up to Week 60)