Status:
NOT_YET_RECRUITING
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Chronic Rhinosinusitis With Nasal Polyposis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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, Pha...
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06930612
Start Date
May 16 2025
End Date
September 16 2026
Last Update
April 16 2025
Active Locations (1)
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1
Beijing Tong-Ren hospital
Beijing, China