Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06930612 | NOT YET RECRUITING | Chronic Rhinosinusitis With Nasal Polyposis

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

Keymed Biosciences Co.Ltd

Brief Summary:

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).

Condition or disease

Chronic Rhinosinusitis With Nasal Polyposis

Intervention/treatment

CM512

Placebo

Phase

PHASE2

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
Estimated Enrollment : 120 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2025-05-16
Estimated Primary Completion Date : 2026-09-16
Estimated Study Completion Date : 2026-09-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）

Location Details

NCT06930612

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China,

Beijing Tong-Ren hospital

Beijing, China,