A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT06707883
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
258 participants
INTERVENTIONAL
2024-12-31
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TQC2731 injection
TQC2731 injection, 28days as a treatment cycle.
TQC2731 injection
TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)
TQC2731 Placebo
TQC2731 Placebo, 28days as a treatment cycle.
TQC2731 Placebo
TQC2731 Placebo without drug substance.
Interventions
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TQC2731 injection
TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)
TQC2731 Placebo
TQC2731 Placebo without drug substance.
Eligibility Criteria
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Inclusion Criteria
* Participant must be ≥40 to ≤80 years of age at the time of signing informed consent.
* Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease(COPD) and a history of COPD ≥12 months with medical records or related records at the time of screening;
* Post-bronchodilator FEV1/Forced vital capacity (FVC)\<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \< 80% during screening.
* Modified Medical Research Council (mMRC) Dyspnea Scale grade≥2 during screening.
* Background triple therapy (ICS+long-acting beta-agonists (LABA)+LAMA) for at least 3 months with a stable dose for at least 1 month prior to randomization; Double therapy allowed if ICS is contraindicated.
* With a history of acute exacerbation of ≥2 moderate or ≥1 severe within the previous 12 months prior to screening. Multiple acute exacerbation events with an interval of less than 14 days are counted as one.
Exclusion Criteria
* Subjects with active pulmonary diseases other than COPD assessed by the investigator.
* Moderate to severe Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) occurred within 4 weeks prior to screening or during screening;
* History of lung transplantation;
* Previous use of TQC2731.
* Diagnosis of alpha-1 anti-trypsin deficiency;
* History of lung volume reduction surgery or pneumonectomy within 6 months prior to randomization, or planned lung volume reduction surgery during the study period;
* Positive hepatitis B surface antigen, or hepatitis C virus antibody, or syphilis antibody.
* Diagnosis of immunodeficiency, including but not limited to HIV infection;
* Infection requiring systemic therapy within 2 weeks prior to randomization.
* Starting rehabilitation within 4 weeks prior to randomization, or planned rehabilitation during the study period;
* Treatment with oxygen of more than 12 hours per day.
* Heart failure New York Heart Association (NYHA) class III or IV during the screening period.
* History of malignancy within 5 years prior to screening, excluding cervical carcinoma in situ, ductal carcinoma in situ, etc.
* Pregnancy or breastfeeding.
40 Years
80 Years
ALL
No
Sponsors
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Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First People's Hospital of Chuzhou
Chuzhou, Anhui, China
The second hospital of ANHUI medical university
Hefei, Anhui, China
Huainan Dongfang Hospital Group General Hospital
Huainan, Anhui, China
Capital Medical University Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Shunde Hospital Of Southern Medical University
Foshan, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Nanxishan Hospital of Guangxi Zhuang Autonomous
Guilin, Guangxi, China
The First People' Hospital Of YuLin
Yulin, Guangxi, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Jiaozuo Second People's Hospital
Jiaozuo, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Henan Chest Hospital
Zhengzhou, Henan, China
Jianghan University Affiliated Hospital (Wuhan Sixth Hospital)
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Changsha First Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangtan County People's Hospital
Xiangtan, Hunan, China
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin, Jiangsu, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Yixing People'S Hospital
Wuxi, Jiangsu, China
XuZhou Central Hospital
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Xinyu People'S Hospital
Xinyu, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Anshan Iron and Steel Group Corporation
Anshan, Liaoning, China
Benxi Central Hospital
Benxi, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Heze Municipal Hospital
Heze, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Weifang NO.2 People' Hospital
Weifang, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Affiliated Hospital Of ChengDu University
Chengdu, Sichuan, China
Guangyuan Central Hospital
Guangyuan, Sichuan, China
Leshan People's Hospital
Leshan, Sichuan, China
Meishan People's Hospital
Meishan, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
Taizhou Central Hospital Central Hospital
Taizhou, Zhejiang, China
The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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TQC2731-II-04
Identifier Type: -
Identifier Source: org_study_id
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