biostudies-literatureUnknown16(1)Xian MTo explore the therapeutic potential of blocking thymic stromal lymphopoietin (TSLP) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), we conducted a phase 1b/2a, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of CM326, a monoclonal antibody against TSLP. We enrolled 84 eligible patients with uncontrolled CRSwNP and stratified them based on baseline tissue eosinophil count. Patients are assigned to receive CM326 220 mg (n = 40) or placebo (n = 20) every 2 weeks (Q2W) and CM326 220 mg (n = 20) or placebo (n = 4) every 4 weeks (Q4W) for 16 weeks. Subsequently, all patients continue on CM326 220 mg Q2W or Q4W for an additional 36 weeks, followed by a 12-week follow up. Primary endpoints are safety of CM326 and change from baseline in NPSNature communications8607https://www.ebi.ac.uk/biostudies/studies/S-EPMC12480939biostudies-literatureAn anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial.PMC12480939Fang HLan FJiang LYu SWang CWan LSu LWei XLiu SZhang LZhang QWang LJiang YQu SZhao GShen SSong XXue JYang GXie YChen JTan GXiao ZLi QChen BYang YXian MZhang YYan BLuo XYan HLiu FYe JXu YfalseAn anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial.To explore the therapeutic potential of blocking thymic stromal lymphopoietin (TSLP) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), we conducted a phase 1b/2a, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of CM326, a monoclonal antibody against TSLP. We enrolled 84 eligible patients with uncontrolled CRSwNP and stratified them based on baseline tissue eosinophil count. Patients are assigned to receive CM326 220 mg (n = 40) or placebo (n = 20) every 2 weeks (Q2W) and CM326 220 mg (n = 20) or placebo (n = 4) every 4 weeks (Q4W) for 16 weeks. Subsequently, all patients continue on CM326 220 mg Q2W or Q4W for an additional 36 weeks, followed by a 12-week follow up. Primary endpoints are safety of CM326 and change from baseline in NPS2025-01-01T00:00:00Z2025 Sep2026-06-04T01:46:52.251Z2026-05-04T03:13:48.986ZS-EPMC124809394102284810.1038/s41467-025-63682-x