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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07807826

Enrollment

240

Registered

2026-09-08

Start date

2026-10-01

Completion date

2028-07-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Brief summary

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)

Detailed description

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.

Interventions

BIOLOGICALCM512

subcutaneous injection

DRUGPlacebo

subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in the Nasal Polyps Score (NPS) at week 24	At week 24	NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Change from baseline in the Nasal Congestion Score (NCS) at week 24	At week 24	Congestion Score is scored on a scale of 0 to 3.higher score means a worse outcome.

Countries

China

Contacts

CONTACTQian Jia

clinicaltrial@keymedbio.com028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026