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TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

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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.

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