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

Phase 2

Not yet recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyposis
• Interventions: Biological: CM512; Drug: Placebo

• Registration Number: NCT06930612
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief 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).

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-05-16
• Primary Completion: 2026-09-16
• Study Completion: 2026-09-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
• Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM512 Dose 1	CM512	-
CM512 Dose 2	CM512	-
CM512 Dose 3	CM512	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Nasal Polyps Score (NPS)	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.

Trial Locations

Locations (1)

Beijing Tong-Ren hospital; 🇨🇳 Beijing, China