Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis

Launched by KEYMED BIOSCIENCES CO.LTD · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial, called the "Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis," is looking to see how well a new treatment called CM326 works for people suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). Chronic rhinosinusitis is a long-lasting condition that causes inflammation in the sinuses, often leading to nasal congestion, sinus pressure, and the growth of polyps, which are non-cancerous growths in the nasal passages. The study will also check the safety of CM326 and how the body processes this treatment.

To take part in the trial, participants need to be between 18 and 75 years old and have had prior treatment with systemic corticosteroids (a type of medication often used to reduce inflammation) within the last two years, or have had surgery for nasal polyps in the six months before joining the study. Not everyone can participate, though; individuals with certain allergies or who have taken specific treatments recently won’t be eligible. If you join this study, you will be randomly assigned to receive either CM326 or a placebo (a treatment that doesn’t contain the active drug) without knowing which one you have. The study is not yet recruiting participants, but it aims to help improve treatment options for those with CRSwNP.

Gender

ALL

Eligibility criteria

• 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.