研究单位:[1]Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.[2]The People''s Hospital of Bozhou,Bozhou,Anhui,China,236000[3]Anhui Chest Hoispital,Hefei,Anhui,China,230022[4]The First Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400010[5]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361000[6]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730000[7]The First Hospital of Lanzhou University,Lanzhou,Gansu,China,730000[8]Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,Guangdong,China,510120[9]Guangzhou First People''s Hospital,Guangzhou,Guangdong,China,510180[10]Third People''s Hospital of Huizhou,Huizhou,Guangdong,China,516002[11]Zhongshan City People''s Hospital,Zhongshan,Guangdong,China,528403[12]The Affiliated Hospital of Medical University,Guilin,Guangxi,China,541000[13]Guizhou Provincial People''s Hospital,Guiyang,Guizhou,China,550000[14]Cangzhou Hospital of Integrated TCM-WM·Hebei,Cangzhou,Hebei,China,061000[15]Xingtai People''s Hospital,Xingtai,Hebei,China,054001[16]Da Qing Long Nan Hospital,Daqing,Heilongjiang,China,163453[17]The Fourth Affiliated Hospital of Harbin Medical University,Ha''erbin,Heilongjiang,China,150001[18]Qiqihar First People''s Hospital,Qiqihar,Heilongjiang,China,161000[19]The Second People''s Hospital of Jiaozuo City,Jiaozuo,Henan,China,454001[20]Luo Yang Dong Fang People''s Hospital,Luoyang,Henan,China,471003[21]Zhoukou Central hospital,Zhoukou,Henan,China,466000[22]The Central Hospital of Wuhan,Wuhan,Hubei,China,430000[23]Changsha Central Hospital,Changsha,Hunan,China,410000[24]Hunan Provincial People''s Hospital (The First Affiliated Hospital of Hunan Normal University),Changsha,Hunan,China,410021[25]Loudi central hospital,Loudi,Hunan,China,417000[26]Baotou Central Hospital,Baotou,Inner Mongolia,China,014040[27]The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology,Baotou,Inner Mongolia,China,14000[28]Chifeng Municipal Hospital,Chifeng,Inner Mongolia,China,024099[29]The Affiliated Hospital of Inner Mongolia Medical University,Hohhot,Inner Mongolia,China,100000[30]Inner Mongolia Autonomous Region People''s Hospital,Hohhot,Inner Mongolia,China,100017[31]The Second People Hospital''s of Lianyungang,Lianyungang,Jiangsu,China,222006[32]Jiangsu Provincial People''s Hospital,Nanjing,Jiangsu,China,210029[33]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China,221000[34]Xuzhou Central Hospital,Xuzhou,Jiangsu,China,221000[35]Northern Jiangsu People''s Hospital,Yangzhou,Jiangsu,China,225001[36]Jiangsu University Affiliated Hospital,Zhenjiang,Jiangsu,China,212001[37]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330038[38]Pingxiang People''s Hospital,Pingxiang,Jiangxi,China,337055[39]Jilin University Second Hospital,Changchun,Jilin,China,130000[40]The First Hospital of Jlin University,Changchun,Jilin,China,130000[41]Gansu Provincial Hospital,Gansu,Lanzhou,China,730000[42]Dalian Municipal Central Hospital,Dalian,Liaoning,China,116021[43]Genertec Liaoyou Gem Flower Hospital,Panjin,Liaoning,China,124000[44]Shengjing Hospital of China Medical University,Shenyang,Liaoning,China,110000[45]People''s Liberation Army North Theater General Hospital,Shenyang,Liaoning,China,130012[46]The First People''s Hospital of Yinchuan,Yinchuan,Ningxia,China,750001[47]The First Affiliated Hospital of Xi''an Jiaotong University,Xi''an,Shaanxi,China,710000[48]The First Affiliated Hospital of Xi''an Medical Universi,Xi''an,Shaanxi,China,710000[49]The Second Affiliated Hospital of Xi''an Jiaotong University,Xi''an,Shaanxi,China,710000[50]Xi''an International Medical Center Hospital,Xi''an,Shaanxi,China,710000[51]Heze Municipal Hospital,Heze,Shandong,China,274031[52]Affiliated Hospital of Jining Medical Hospital,Jining,Shandong,China,272000[53]Weifang NO.2 People''s Hospital,Weifang,Shandong,China,261041[54]Yantai Yuhuangding Hospital,Yantai,Shandong,China,264099[55]Zaozhuang Municipal Hospital,Zaozhuang,Shandong,China,277000[56]Rui Jin Hospital Shanghai Jiaotong University School of Medical,Shanghai,Shanghai,China,200025[57]Fudan University Affiliated Zhongshan Hospital,Shanghai,Shanghai,China,200032[58]Shanghai General Hospital,Shanghai,Shanghai,China,200080[59]Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center,Shanghai,Shanghai,China,200120[60]Shanghai Tongren Hospital,Shanghai,Shanghai,China,200336[61]Wusong Central Hospital, Baoshan District, Shanghai,Shanghai,Shanghai,China,200940[62]Shanxi Bethune Hospital,Taiyuan,Shanxi,China,030032[63]Yangquan Coal Industry Group General Hospital,Yangquan,Shanxi,China,45000[64]Suining Central Hospital,Suining,Sichuan,China,629000[65]Tianjin Medical University General Hospital,Tianjin,Tianjin,China,300052[66]Tianjin 4th Center Hospital,Tianjin,Tianjin,China,300140[67]The First Affiliated Hospital of Shihezi University,Shihezi,Xinjiang,China,832008[68]First Affiliated Hospital of Xinjiang Medical University,Ürümqi,Xinjiang,China,830000[69]Xinjiang Uiger Municipal People''S Hospital,Ürümqi,Xinjiang,China,830000[70]The First People''s Hospital of Yunnan Province,Kunming,Yunnan,China,650000[71]The People''s Hospital of Yuyao,Yuyao,Zhejaing,China,315400[72]Jinhua Municipal Central Hospital,Jinhua,Zhejiang,China,321000[73]The First Affiliated Hospital of Ningbo University,Ningbo,Zhejiang,China,315020[74]Taizhou Central Hospital(Taizhou University Hospital),Taizhou,Zhejiang,China,318000[75]Wenzhou Medical University Affiliated Second Hospital,Wenzhou,Zhejiang,China,325000
研究目的:
This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.