Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- CM326
- Placebo
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov