NCT06930612

A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double blind, placebo-controlled Phase II 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).

Detailed description

The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).

Conditions

• Chronic Rhinosinusitis With Nasal Polyposis

Interventions

Type	Name	Description
BIOLOGICAL	CM512	Administered subcutaneous injection
DRUG	Placebo	Administered subcutaneous injection

Timeline

• Start date: 2025-05-16
• Primary completion: 2026-09-16
• Completion: 2026-09-16
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: China