Status:
COMPLETED
A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Chronic Rhinosinusitis With Nasal Polyposis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Ph...
Detailed Description
The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period and 28 weeks for open-label maintenance treatment) and Safety Follow-up Period (8...
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.
- NCS score of 2 or 3 at screening period, and at least 2 at baseline.
- Contraception.
Exclusion
- Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
- Participated and any studies of CM310.
- With malignant or benign tumor of nasal cavity.
- Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05436275
Start Date
August 9 2022
End Date
June 25 2024
Last Update
November 8 2024
Active Locations (1)
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1
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China