A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-3)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyps

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)

This study consists of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period + 24-week maintenance treatment period), and a 12-week safety follow-up period.

Inclusion Criteria:

• with chronic rhinosinusitis with nasal polyposis (CRSwNP)
• Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity
• Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline
• Contraception

Exclusion Criteria:

• 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 systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity