drugset / Trial / NCT05324137
A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.
Timeline
- Start
- 2022-07-11
- Primary completion
- 2024-03-29
- Completion
- 2024-03-29
Publications
- Xian M, Lan F, Yan B, Shen S, Liu S, Wan L, Song X, Jiang L, Jiang Y, Xue J, Chen J, Su L, Ye J, Yang Y, Fang H, Tan G, Zhang Q, Qu S, Wei X, Luo X, Xu Y, Yu S, Xiao Z, Liu F, Li Q, Zhang Y, Xie Y, Wang L, Yang G, Yan H, Zhao G, Chen B, Wang C, Zhang L. An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial. Nat Commun. 2025 Sep 29;16(1):8607. doi: 10.1038/s41467-025-63682-x.
- Shen S, Xian M, Yan B, Lan F, Wang C, Zhang L. Anti-thymic stromal lymphopoietin monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps (DUBHE): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled study. Asia Pac Allergy. 2024 Mar;14(1):26-31. doi: 10.5415/apallergy.0000000000000135. Epub 2024 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OCANKITUG | Monoclonal antibody | 55 mg | Subcutaneous |
| Subject | OCANKITUG | Monoclonal antibody | 110 mg | Subcutaneous |
| Subject | OCANKITUG | Monoclonal antibody | 220 mg | Subcutaneous |