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RECRUITING Phase 3 ClinicalTrials.gov

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection

Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. • ClinicalTrials.gov ID: NCT06829784

Registry updated: 2026-08-19
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Description

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 trial participants are expected to be enrolled, with trial participants randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.

Interventions

  • TQC2731 injection (Drug)
    TQC2731 injection can specifically bind to the Thymic Stromal Lymphopoietin (TSLP) protein, blocking TSLP-dependent downstream signaling expression in engineered cells and inhibiting the production of inflammatory cytokines.
  • Placebo (Drug)
    Placebo without drug substance.

Eligibility criteria

Inclusion Criteria: * Sign the informed consent form before the trial to fully understand the purpose, process and possible adverse reactions of the trial; * Age 18 \~ 75 years old, gender is not limited; * Documented physician diagnosis of asthma at least 12 months prior to Visit 1; * Subjects who received high-dose Inhaled Corticosteroids (ICS) in asthma control medications prescribed by their physicians at least 6 months prior to Visit 1; * There must be a record of receiving a stable total daily dose of ICS at least 3 months prior to visit 1; * There must be a record of the use of other asthma control medications at a stable dose at least 3 months prior to visit 1; For subjects taking maintenance oral hormones, the dose of oral hormones is up to 10mg prednisone per day or 20mg every other day (or equivalent) and must be stable for at least 30 days prior to visit 1 and during treatment. * Documented at least 2 asthma exacerbations in the 12 months prior to Visit 1 and no major asthma exacerbation events in the 1 month prior to signing informed. Exclusion Criteria: * Have a clinically significant lung disease other than asthma; * Pre-existing autoimmune disease; * A history of known or suspected immunosuppression, including a history of invasive opportunistic infections; * Any disease that has not been determined to be stable by the investigator; * Cancer history: Patients with basal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinoma in situ are eligible to be enrolled in this study if they had completed curative therapy for at least 12 months prior to visit 1. Patients with other malignancies who had completed curative treatment for at least 5 years prior to visit 1 could be enrolled in the study. * Current smoker or smoking history ≥10 pack-years (former smokers with smoking history \<10 pack-years had quit smoking less than 6 months before interview 1); * Other factors determined by the investigator that subjects were not suitable to participate in the study.

Conditions

Asthma

Locations

  • The People's Hospital of Bozhou — Bozhou, Anhui, China
  • Anhui Chest Hoispital — Hefei, Anhui, China
  • The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
  • Lu'an People's Hospital of Anhui Province — Lu'an, Anhui, China
  • Tongling People's Hospital — Tongling, Anhui, China
  • Peking University First Hospital — Beijing, Beijing Municipality, China
  • Beijing No.6 Hospital — Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
  • Zhangzhou Municipal Hospital of Fujian — Zhangzhou, Fujian, China
  • The First Hospital of Lanzhou University — Lanzhou, Gansu, China
  • The Second Hospital & Clinical Medical School,Lanzhou University — Lanzhou, Gansu, China
  • The Eighth Afliated Hospital of Southern Medical University The First people's Hospital of Shunde — Foshan, Guangdong, China
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China
  • Guangzhou First People's Hospital — Guangzhou, Guangdong, China
  • Third People's Hospital of Huizhou — Huizhou, Guangdong, China
  • Zhongshan City People's Hospital — Zhongshan, Guangdong, China
  • The Affiliated Hospital of Medical University — Guilin, Guangxi, China
  • Guilin People'S Hospital — Guilin, Guangxi, China
  • Guizhou Provincial People's Hospital — Guiyang, Guizhou, China
  • The First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China
  • Cangzhou Hospital of Integrated TCM-WM·Hebei — Cangzhou, Hebei, China
  • Xingtai People's Hospital — Xingtai, Hebei, China
  • Da Qing Long Nan Hospital — Daqing, Heilongjiang, China
  • The Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
  • The First Hospital of Qiqihar — Qiqihar, Heilongjiang, China
  • The People's Hospital of Anyang — Anyang, Henan, China
  • The Second People's Hospital of Jiaozuo City — Jiaozuo, Henan, China
  • Luo Yang Dong Fang People's Hospital — Luoyang, Henan, China
  • Xinxiang Central Hospital — Xinxiang, Henan, China
  • Henan Provincial People's Hospital — Zhengzhou, Henan, China
  • Zhengzhou Central Hospital — Zhengzhou, Henan, China
  • Zhoukou Central hospital — Zhoukou, Henan, China
  • Enshi Tujia and Miao Autonomous Prefecture Central Hospital — Enshi, Hubei, China
  • The Central Hospital of Wuhan — Wuhan, Hubei, China
  • Changsha Central Hospital — Changsha, Hunan, China
  • The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
  • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) — Changsha, Hunan, China
  • Loudi central hospital — Loudi, Hunan, China
  • Baotou Central Hospital — Baotou, Inner Mongolia, China
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology — Baotou, Inner Mongolia, China
  • Chifeng Municipal Hospital — Chifeng, Inner Mongolia, China
  • The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
  • Inner Mongolia Autonomous Region People's Hospital — Hohhot, Inner Mongolia, China
  • Affiliated Hospital of Jiangsu University — Nanjing, Jiangsu, China
  • Wuxi Second People's Hospital — Wuxi, Jiangsu, China
  • The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
  • Xuzhou Central Hospital — Xuzhou, Jiangsu, China
  • Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China
  • Jiangsu University Affiliated Hospital — Zhenjiang, Jiangsu, China
  • The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • Pingxiang People's Hospital — Pingxiang, Jiangxi, China
  • Jilin University Second Hospital — Changchun, Jilin, China
  • The First Hospital of Jlin University — Changchun, Jilin, China
  • Gansu Provincial Hospital — Gansu, Lanzhou, China
  • Dalian Municipal Central Hospital — Dalian, Liaoning, China
  • Genertec Liaoyou Gem Flower Hospital — Panjin, Liaoning, China
  • Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China
  • Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
  • People's Liberation Army North Theater General Hospital — Shenyang, Liaoning, China
  • The First People's Hospital of Yinchuan — Yinchuan, Ningxia, China
  • The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
  • The First Affiliated Hospital of Xi'an Medical Universi — Xi'an, Shaanxi, China
  • The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
  • Xi'an International Medical Center Hospital — Xi'an, Shaanxi, China
  • Xi'an People's Hospital (Xi'an Fourth Hospital) — Xi'an, Shaanxi, China
  • Heze Municipal Hospital — Heze, Shandong, China
  • Central Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China
  • Affiliated Hospital of Jining Medical Hospital — Jining, Shandong, China
  • The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
  • The Second Affiliated Hospital of Shandong First Medical University — Tai’an, Shandong, China
  • Weifang NO.2 People's Hospital — Weifang, Shandong, China
  • Yantai Yuhuangding Hospital — Yantai, Shandong, China
  • Zaozhuang Municipal Hospital — Zaozhuang, Shandong, China
  • Zibo Central Hospital — Zibo, Shandong, China
  • Rui Jin Hospital Shanghai Jiaotong University School of Medical — Shanghai, Shanghai Municipality, China
  • Fudan University Affiliated Zhongshan Hospital — Shanghai, Shanghai Municipality, China
  • Shanghai General Hospital — Shanghai, Shanghai Municipality, China
  • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center — Shanghai, Shanghai Municipality, China
  • Wusong Central Hospital, Baoshan District, Shanghai — Shanghai, Shanghai Municipality, China
  • Jincheng General Hospital — Jincheng, Shanxi, China
  • Shanxi Bethune Hospital — Taiyuan, Shanxi, China
  • No.215 Hospital of Shaanxi Nuclear Industry — Xianyang, Shanxi, China
  • Yangquan Coal Industry Group General Hospital — Yangquan, Shanxi, China
  • West China Hospital, Sichuan University — Chengdu, Sichuan, China
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
  • Chengdu Fifth People's Hospital — Chengdu, Sichuan, China
  • Suining Central Hospital — Suining, Sichuan, China
  • Yibin Second People's Hospital — Yibin, Sichuan, China
  • Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China
  • Tianjin 4th Center Hospital — Tianjin, Tianjin Municipality, China
  • The First Affiliated Hospital of Shihezi University — Shihezi, Xinjiang, China
  • First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China
  • People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China
  • The First People's Hospital of Yunnan Province — Kunming, Yunnan, China
  • The First Affiliated of Kumming Medical University — Kunming, Yunnan, China
  • The People's Hospital of Yuyao — Yuyao, Zhejaing, China
  • Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China
  • The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
  • Taizhou Central Hospital(Taizhou University Hospital) — Taizhou, Zhejiang, China
  • The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou, Zhejiang, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record