Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372678
• Other study ID #: CM326-102102
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: 028-88610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Description:

Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of the sinus mucosa. Chronic rhinosinusitis can be clinically divided into chronic rhinosinusitis without nasal polyps (CRSsNP) and chronic sinusitis with nasal polyps (CRSwNP), with an incidence ratio between the two of about 4:1. Patients with CRSwNP usually show more severe clinical symptoms and are more likely to relapse after surgery. The overall prevalence of chronic rhinosinusitis in our country is 8%, of which 11.2% are accompanied by asthma. The prevalence of chronic rhinosinusitis with nasal polyps (CRSwNP) is 1.1%. With changes in the living environment and acceleration of urbanization in China, the overall morbidity is estimated to keep rising.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female subjects, aged between 18 and 75 years old (inclusive).
• Subjects who are capable of understanding the nature of the study and voluntarily signing the Informed consent form (ICF).
• Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.

Exclusion Criteria:

• Allergic or intolerant to mometasone furoate spray or CM326.
• Have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
• Participated study of CM326.
• Systemic immunosuppressive therapy for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to baseline (whichever is longer).
• Starting leukotriene receptor antagonist therapy within 4 weeks prior to baseline.
• With antrochoanal polyps.
• With severe deviation of the nasal septum occludes at least one nostril.
• With persistent rhinitis medicamentosas.
• With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
• Have symptoms or whose CT scan suggests allergic fungal sinusitis.
• With malignant or benign neoplasm of nasal cavities.
• With other uncontrolled serious diseases or recurrent chronic diseases.
• Have severe hepatic and renal impairment.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Rhinosinusitis
• Sinusitis

Intervention

Biological:
• CM326
CM326 injection

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, CMU	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24.		Up to week 24