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

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis

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).

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis With Nasal Polyposis
• Intervention / Treatment: Biological: CM310; Biological: Placebo

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Tongren Hospital, CMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM310; CM310 300mg is given subcutaneously (SC) every two weeks	Biological: Placebo; once every two weeks
Placebo Comparator: Placebo; Placebo is given subcutaneously (SC) every two weeks	Biological: CM310; 300 mg every two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Polyps Score (NPS)	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.	at week 24
Nasal Congestion Score (NCS)	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.	at week 24

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd
• Investigators: Principal Investigator: Luo Zhang, Beijing Tong-Ren hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Head and Neck Neoplasms; Colonic Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Rhinitis; Paranasal Sinus Diseases; Polyps; Rhinosinusitis; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps; Sinusitis
• Other Study ID Numbers: CM310-102208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No