drugset / Trial / NCT07420257

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

NCT07420257 ↗

Phase 3 Not yet recruiting 212 enrolled CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-02-28
Primary completion
2028-10-30
Completion
2028-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject OCANKITUG Monoclonal antibody — Subcutaneous