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NCT Number: NCT07519577

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

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

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyposis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM512

Biological

Administered subcutaneous injection

Primary outcomes

  1. Occurrence of adverse events

    Time frame: Up to week 60

    Incidences of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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