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An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial

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作者：
Xian Mu[1,2,3] * ; Lan Feng[1,2,3] ; Yan Bing[1,2,3] ; Shen Shen[1,2,3] ; Liu Shixi[4] ; Wan Lijia[5] ; Song Xicheng[6,7] ; Jiang Luyun[8] ; Jiang Yan[9] ; Xue Jinmei[10] ; Chen Jianjun[11] ; Su Lizhong[12,13] ; Ye Jing[14] ; Yang Yucheng[15] ; Fang Hongyan[16] ; Tan Guolin[17] ; Zhang Qinna[18] ; Qu Shenhong[19] ; Wei Xin[20] ; Luo Xianyang[21] ; Xu Yu[22,23] ; Yu Shaoqing[24,25] ; Xiao Zian[26] ; Liu Feng[4] ; Li Qin[5] ; Zhang Yu[6,7] ; Xie Yan[8] ; Wang Lin[9] ; Yang Guoping[27] ; Yan Hongyue[28] ; Zhao Guoqing[28] ; Chen Bo[28] ; Wang Chengshuo[29,30,31] ; Zhang Luo[32,33,34,35] ;
机构： [1]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. [4]Department of Otorhinolaryngology, Head and Neck Surgery, West China Hospital Sichuan University, Chengdu, Sichuan, China. [5]Department of Otorhinolaryngology, Head and Neck Surgery, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, Hubei, China. [6]Department of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, China. [7]Shandong Provincial Clinical Research Centre for Otorhinolaryngologic Diseases, Yantai, Shandong, China. [8]Department of Otorhinolaryngology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China. [9]Department of Otorhinolaryngology, Head and Neck Surgery, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. [10]Department of Otorhinolaryngology, Head and Neck Surgery, the Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China. [11]Department of Otorhinolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China. [12]Department of Otolaryngology, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China. [13]Centre of Otolaryngology Head and Neck Surgery, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China. [14]Department of Otorhinolaryngology, Head and Neck Surgery, the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China. [15]Department of Otorhinolaryngology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China. [16]Department of Otorhinolaryngology, Head and Neck Surgery, Chongqing General Hospital, Chongqing, China. [17]Department of Otorhinolaryngology, Head and Neck Surgery, the Third Xiangya Hospital of Central South University, Changsha, Hunan, China. [18]Department of Otorhinolaryngology, Head and Neck Surgery, the First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China. [19]Department of Otolaryngology, Head and Neck Surgery, The People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China. [20]Department of Otorhinolaryngology Head and Neck Surgery, Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University, Haikou, Hainan, China. [21]Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China. [22]Department of Rhinology and Allergy, Renmin Hospital of Wuhan University, Wuhan, Hubei, China. [23]Otolaryngology-Head and Neck Surgery Centre, Renmin Hospital of Wuhan University, Wuhan, Hubei, China. [24]Department of Otolaryngology Head and Neck Surgery, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. [25]Department of Allergy, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China. [26]Department of Otorhinolaryngology, Head and Neck Surgery, the Second Xiangya Hospital of Central South University, Changsha, Hunan, China. [27]Centre for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China. [28]Keymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China. [29]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. wangcs830@126.com. [30]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. wangcs830@126.com. [31]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. wangcs830@126.com. [32]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com. [33]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. dr.luozhang@139.com. [34]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. dr.luozhang@139.com. [35]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com.
出处：
DOI： 10.1038/s41467-025-63682-x

摘要：
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 NPS at week 16 in patients with eosinophilic CRSwNP (ECRSwNP). Main secondary endpoints include the change from baseline in NPS at week 16 in non-eosinophilic CRSwNP (nonECRwNP) and pharmacodynamic markers. Throughout the 64-week study, all treatment-emergent adverse events (TEAEs) are mild or moderate. CM326 Q2W improves NPS in patients with ECRSwNP compared with placebo at week 16 (mean difference [95% CI], -1.2 [-2.3 to -0.1], P = 0.04), with sustained benefits during the open-label and follow-up periods. Notably, peripheral blood and tissue eosinophil counts and concentrations of plasma IL-13 and IL-5 are reduced by week 16 with the treatment of CM326 Q2W versus placebo. A post-hoc analysis demonstrates that all participants with baseline TSLP > 330 fg/mL achieve a substantial reduction in NPS by week 16 with the treatment of CM326 Q2W (mean difference vs. placebo: -1.75 [95%CI, -3.06 to -0.44], P = 0.01). Overall, CM326 is well tolerated and effective in patients with uncontrolled ECRSwNP. A baseline plasma TSLP level of 330 fg/mL may serve as a predictive marker for treatment efficacy of CM326. ClinicalTrials.gov Identifier: NCT05324137.© 2025. The Author(s).

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出版当年[2025]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
最新[2025]版：
大类 | 1 区 综合性期刊
小类 | 1 区 综合性期刊
第一作者：
第一作者机构： [1]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. [2]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. [3]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China.
通讯作者：
通讯机构： [29]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. wangcs830@126.com. [30]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. wangcs830@126.com. [31]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. wangcs830@126.com. [32]Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com. [33]Beijing Institute of Otolaryngology, Beijing Laboratory of Allergic Diseases, Beijing Key Laboratory of New Medicine and Diagnostic Technology Research for Nasal Disease, Key Laboratory of Otolaryngology Head and Neck Surgery, Ministry of Education, Capital Medical University, Beijing, China. dr.luozhang@139.com. [34]Research Unit of Diagnosis and Treatment of Chronic Nasal Diseases, Chinese Academy of Medical Sciences, Beijing, China. dr.luozhang@139.com. [35]Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com.
推荐引用方式(GB/T 7714)：
Xian Mu,Lan Feng,Yan Bing,et al.An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial[J].Nature Communications.2025,16(1):8607.doi:10.1038/s41467-025-63682-x.
APA：
Xian Mu,Lan Feng,Yan Bing,Shen Shen,Liu Shixi...&Zhang Luo.(2025).An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial.Nature Communications,16,(1)
MLA：
Xian Mu,et al."An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial".Nature Communications 16..1(2025):8607

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