Clinical Trial

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

Not Yet Recruiting Phase 3
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Summary
This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and I immumogenicity\[c2.1\] of CM326 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The study consists of four periods, including an up to 4-week screening/run-in period, a 24-week double-blind randomized treatment period, a 28-week open-label treatment period, and an 8-week safety follow-up period.
Trial Details
NCT Number NCT07420257
Lead Sponsor CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Conditions Chronic Rhinosinusitis With Nasal Polyps
Enrollment 212 participants
Start Date 2026-02-28
Primary Completion 2028-10-30 (estimated)
Study Completion 2028-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-19