A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）

Summary

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Timeline

Start

2022-08-09

Primary completion

2024-06-25

Completion

2024-06-25

Publications

• Shen S, Yan B, Wang M, Wu D, Piao Y, Tang J, Yang X, Cao Z, Xue J, Liu W, Liu S, Shi L, Wang G, Song X, Lu Y, Chen J, Jiang L, Ye J, Yu S, Yang Y, Fang H, Li J, Shi H, Fan J, Yan H, Wang H, Chen B, Wang C, Zhang L; CROWNS-2 Study Investigators. Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: The CROWNS-2 Randomized Clinical Trial. JAMA. 2025 Aug 18;334(11):962-72. doi: 10.1001/jama.2025.12515. Online ahead of print.
• Shen S, Yan B, Wang M, Wu D, Wang C, Zhang L. Anti-IL-4Ralpha monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Asia Pac Allergy. 2024 Aug;14(3):118-123. doi: 10.5415/apallergy.0000000000000156. Epub 2024 Aug 5.

Drugs

Indications