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Not yet recruiting NCT07519577

A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-2）

Phase II Interventional Chronic Rhinosinusitis With Nasal Polyposis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CM512.
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis With Nasal Polyposis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Single-Arm, Multicenter, Extension Study to Evaluate the Safety and Efficacy of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis

Overview

This is an open-label, single-arm, multicenter, extension study to evaluate the safety and efficacy of CM512 in patients With Chronic Rhinosinusitis with Nasal Polyposis

Interventions

  • Biological CM512
    Administered subcutaneous injection

Primary outcome measures

  • Occurrence of adverse events [Time frame: Up to week 60]

Eligibility criteria

Inclusion criteria

  • Participated in the clinical study of CM512 in patients with Chronic Rhinosinusitis with Nasal Polyposis (Study No. of CM512-102101) .

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.
  • Administration of a live attenuated vaccine within 30 days prior to baseline or planning to receive one during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tong-Ren hospital — Beijing

Identifiers

NCT: NCT07519577 · CM512-102103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗