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Completed

NCT Number: NCT06930612

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

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).

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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

Beijing Tong-Ren hospital

Beijing, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CM512

Biological

Administered subcutaneous injection

Placebo

Drug

Administered subcutaneous injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from baseline in NPS at other visits

    Time frame: baseline up to week 36

  2. Change from baseline in Nasal Congestion Score (NCS) at each visit

    Time frame: baseline up to week 36

  3. 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

  4. Change from baseline in Total Symptom Score (TSS) at each visit

    Time frame: baseline up to week 36

  5. Change from baseline in Loss of Smell (LoS) score at each visit

    Time frame: baseline up to week 36

  6. Change from baseline in Lund-Mackay (LMK) score evaluated by sinus computed tomography (CT) at each visit

    Time frame: baseline up to week 36

  7. Change from baseline in 22-item Sino-nasal Outcome Test (SNOT-22) score at each visit

    Time frame: baseline up to week 36

  8. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: baseline up to week 36

  9. physical examination

    Time frame: baseline up to week 36

  10. vital signs

    Time frame: baseline up to week 36

  11. 12-lead electrocardiogram (ECG)

    Time frame: baseline up to week 36

  12. clinical laboratory tests

    Time frame: baseline up to week 36

  13. Concentration of CM512 in serum

    Time frame: baseline up to week 36

  14. 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

  15. Change from baseline and percent change from baseline in peripheral blood eosinophil (EOS) level at each visit

    Time frame: baseline up to week 36

  16. 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

  17. 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

  18. 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

  19. 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

  20. Change from baseline and percent change from baseline in serum eotaxin-3 level at each visit

    Time frame: baseline up to week 36

  21. Change from baseline and percent change from baseline in serum chemokine 13 (CCL13) level at each visit

    Time frame: baseline up to week 36

  22. Change from baseline and percent change from baseline in serum chemokine 22 (CCL22) level at each visit

    Time frame: baseline up to week 36

  23. Change from baseline and percent change from baseline in serum periostin level at each visit.

    Time frame: baseline up to week 36

  24. Change from baseline and percent change from baseline in EOS levels in nasal polyp biopsy tissue

    Time frame: baseline up to week 24

  25. Incidence of Anti-drug antibodies (ADA)

    Time frame: baseline up to week 36

Sponsors and collaborators

Lead sponsor

Beijing Keymed Biosciences Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Aug 18, 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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