A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24.
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 CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
详细描述
Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of the sinus mucosa. Chronic rhinosinusitis can be clinically divided into chronic rhinosinusitis without nasal polyps (CRSsNP) and chronic sinusitis with nasal polyps (CRSwNP), with an incidence ratio between the two of about 4:1. Patients with CRSwNP usually show more severe clinical symptoms and are more likely to relapse after surgery. The overall prevalence of chronic rhinosinusitis in our country is 8%, of which 11.2% are accompanied by asthma. The prevalence of chronic rhinosinusitis with nasal polyps (CRSwNP) is 1.1%. With changes in the living environment and acceleration of urbanization in China, the overall morbidity is estimated to keep rising.
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
- •Male or female subjects, aged between 18 and 75 years old (inclusive).
- •Subjects who are capable of understanding the nature of the study and voluntarily signing the Informed consent form (ICF).
- •Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.
排除标准
- •Allergic or intolerant to mometasone furoate spray or CM
- •Have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
- •Participated study of CM
- •Systemic immunosuppressive therapy for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to baseline (whichever is longer).
- •Starting leukotriene receptor antagonist therapy within 4 weeks prior to baseline.
- •With antrochoanal polyps.
- •With severe deviation of the nasal septum occludes at least one nostril.
- •With persistent rhinitis medicamentosas.
- •With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
- •Have symptoms or whose CT scan suggests allergic fungal sinusitis.
- •With malignant or benign neoplasm of nasal cavities.
- •With other uncontrolled serious diseases or recurrent chronic diseases.
- •Have severe hepatic and renal impairment.
研究组 & 干预措施
220 mg Group
CM326 220 mg, subcutaneous (SC)
干预措施: CM326 (Biological)
440 mg Group
CM326 440 mg, subcutaneous (SC)
干预措施: CM326 (Biological)
placebo
matched placebo, subcutaneous (SC)
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24.
时间窗: Up to week 24
次要结局
未报告次要终点