A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）

Phase 3

Completed

• Conditions: Chronic Rhinosinusitis With Nasal Polyposis
• Interventions: Biological: CM310; Biological: Placebo

• Registration Number: NCT05436275
• Lead Sponsor: Keymed Biosciences Co.Ltd

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, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

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 weeks).

180 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 12 times at the double-blind treatment period and 14 times at the open-label treatment period. All patients will receive MFNS on a daily basis as a background treatment throughout the study.

Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-29
• Study Start: 2022-08-09
• Status Verified: 2024-06
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.
• NCS score of 2 or 3 at screening period, and at least 2 at baseline.
• Contraception.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	CM310	Placebo is given subcutaneously (SC) every two weeks
CM310	Placebo	CM310 300mg is given subcutaneously (SC) every two weeks

Primary Outcome Measures

Name	Time	Method
Nasal Congestion Score (NCS)	at week 24	Change from baseline in the Nasal Congestion Score (NCS) at week 24. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Nasal Polyps Score (NPS)	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 Outcome Measures

Name	Time	Method
Safety parameters	Baseline up to Week 60	Incidence of treatment-emergent adverse events (TEAEs).
Anti-drug antibodies (ADA)	Baseline up to Week 60	Incidence of ADA.
Pharmacokinetics (PK)	Baseline up to Week 60	Concentration of CM310 in serum
Pharmacodynamics (PD)	Baseline up to Week 60	Change from baseline in serum biomarker level (Thymus- and activation-regulated chemokine).

Trial Locations

Locations (1)

Beijing Tongren Hospital, CMU; 🇨🇳 Beijing, Beijing, China