This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
* Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline
* Contraception
Exclusion Criteria:
* Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity
Primary outcome measure(s)
Change from baseline in the Nasal Polyps Score (NPS) at week 24 — At week 24 NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Change from baseline in the Nasal Congestion Score (NCS) at week 24 — At week 24 Congestion Score is scored on a scale of 0 to 3.higher score means a worse outcome.
Trial sites (1)
Facility
City
Region
Status
Beijing Tongren Hospital, CMU
Beijing
Beijing Municipality
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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