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

August 14, 2026 updated by: Beijing Keymed Biosciences Co., Ltd.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Tong-Ren hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered subcutaneous injection
Experimental: CM512 Dose 1
Biological: CM512
Administered subcutaneous injection
Experimental: CM512 Dose 2
Biological: CM512
Administered subcutaneous injection
Experimental: CM512 Dose 3
Biological: CM512
Administered subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal Polyps Score (NPS)
Time Frame: 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.
at week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in NPS at other visits
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline in Nasal Congestion Score (NCS) at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Proportion of participants achieving an improvement in NPS from baseline of ≥ 1 point and ≥ 2 points at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline in Total Symptom Score (TSS) at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline in Loss of Smell (LoS) score at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline in Lund-Mackay (LMK) score evaluated by sinus computed tomography (CT) at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline in 22-item Sino-nasal Outcome Test (SNOT-22) score at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: baseline up to week 36
baseline up to week 36
physical examination
Time Frame: baseline up to week 36
baseline up to week 36
vital signs
Time Frame: baseline up to week 36
baseline up to week 36
12-lead electrocardiogram (ECG)
Time Frame: baseline up to week 36
baseline up to week 36
clinical laboratory tests
Time Frame: baseline up to week 36
baseline up to week 36
Concentration of CM512 in serum
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum total immunoglobulin E (IgE) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in peripheral blood eosinophil (EOS) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-5 (IL-5) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum interleukin-13 (IL-13) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum thymic stromal lymphopoietin (TSLP) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum thymus and activation-regulated chemokine (TARC) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum eotaxin-3 level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 13 (CCL13) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum chemokine 22 (CCL22) level at each visit
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in serum periostin level at each visit.
Time Frame: baseline up to week 36
baseline up to week 36
Change from baseline and percent change from baseline in EOS levels in nasal polyp biopsy tissue
Time Frame: baseline up to week 24
baseline up to week 24
Incidence of Anti-drug antibodies (ADA)
Time Frame: baseline up to week 36
baseline up to week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Keymed Biosciences Co., Ltd.

Investigators

  • Principal Investigator: Luo Zhang, Beijing Tong-Ren hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Actual)

April 20, 2026

Study Completion (Actual)

July 10, 2026

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM512-102101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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