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Clinical Trials in China / NCT06707883
Active, not recruiting Phase 2

A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT06707883 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase
Phase 2
Started
2024-12-31
Last updated
2025-12-12

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

TQC2731 injectionTQC2731 Placebo

TQC2731 injection: TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP)

TQC2731 Placebo: TQC2731 Placebo without drug substance.

Study summary

To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Able and willing to provide written informed consent and comply with the study protocol; * 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: * COPD with asthma; * 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.

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
The First People's Hospital of Chuzhou Chuzhou Anhui
The second hospital of ANHUI medical university Hefei Anhui
Huainan Dongfang Hospital Group General Hospital Huainan Anhui
Capital Medical University Beijing Chaoyang Hospital Beijing Beijing Municipality
China-Japan Friendship Hospital Beijing Beijing Municipality
The First Hospital of Lanzhou University Lanzhou Gansu
Shunde Hospital Of Southern Medical University Foshan Guangdong
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
Jiangmen Central Hospital Jiangmen Guangdong
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital Qingyuan Guangdong
Zhongshan City People's Hospital Zhongshan Guangdong
Nanxishan Hospital of Guangxi Zhuang Autonomous Guilin Guangxi
The First People' Hospital Of YuLin Yulin Guangxi
Zunyi Medical University Affiliated Hospital Zunyi Guizhou
Cangzhou Central Hospital Cangzhou Hebei
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
Jiaozuo Second People's Hospital Jiaozuo Henan
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
Puyang Oilfield General Hospital Puyang Henan
Henan Chest Hospital Zhengzhou Henan
Jianghan University Affiliated Hospital (Wuhan Sixth Hospital) Wuhan Hubei
Wuhan Central Hospital Wuhan Hubei
Yichang Central People's Hospital Yichang Hubei
Changsha First Hospital Changsha Hunan
Xiangya Hospital of Central South University Changsha Hunan
The Third Xiangya Hospital of Central South University Changsha Hunan
Xiangtan County People's Hospital Xiangtan Hunan
Xiangya Hospital Zhuzhou Central South University Zhuzhou Hunan
Inner Mongolia Autonomous Region People's Hospital Hohhot Inner Mongolia
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
Jiangyin Hospital of Traditional Chinese Medicine Jiangyin Jiangsu
The Fifth People's Hospital of Wuxi Wuxi Jiangsu
Yixing People'S Hospital Wuxi Jiangsu
XuZhou Central Hospital Xuzhou Jiangsu
Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
Jiangxi Provincial People's Hospital Nanchang Jiangxi
Xinyu People'S Hospital Xinyu Jiangxi
The First Hospital of Jilin University Changchun Jilin
General Hospital of Anshan Iron and Steel Group Corporation Anshan Liaoning
Benxi Central Hospital Benxi Liaoning

+ 20 more sites — see the full list on the official registry below.

More Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06707883 on ClinicalTrials.gov ↗ ← All trials in China