A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: TQC2731 injectionDrug: TQC2731 Placebo
- Registration Number
- NCT06707883
- Lead Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
- Brief Summary
To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 258
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQC2731 injection TQC2731 injection TQC2731 injection, 28days as a treatment cycle. TQC2731 Placebo TQC2731 Placebo TQC2731 Placebo, 28days as a treatment cycle.
- Primary Outcome Measures
Name Time Method Annual rate of acute COPD exacerbation Baseline to week 24 Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo
- Secondary Outcome Measures
Name Time Method Change in pre-bronchodilator forced expiratory volume (FEV1) Baseline to week 24 Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo.
Annual rate of acute COPD exacerbation Baseline to week 52 Annualized rate of severe COPD exacerbations over the 52-week treatment period compared to placebo.
Improvement in St. George's Respiratory Questionnaire (SGRQ) Baseline to week 52 Proportion of patients with SGRQ improvement ≥4 points at Week 52
Change in SGRQ Baseline to week 52 Change from baseline to Week 52 in SGRQ total score compared to placebo
Change in pre-bronchodilator FEV1 Baseline to week 52 Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo.
Change in post-bronchodilator FEV1 Baseline to week 24 and 52 Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo.
Change in EXACT Baseline to week 52 Change from baseline to Week 52 in EXACT total score compared to placebo.
Adverse Events (AE) and Serious Adverse Events (SAE) Baseline to 64 weeks The incidence and severity of AE and SAE, as well as abnormal laboratory examination index.
Anti-drug antibodies (ADA) Baseline through week 52 Incidence of ADA.
Immunoglobulin E (IgE) Baseline to 52 weeks Changes in IgE levels in peripheral blood.
Fractional exhaled nitric oxide (FeNO) Baseline to 52 weeks Changes in FeNO.
Related Research Topics
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Trial Locations
- Locations (60)
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, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, 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, China
Shanghai JiaoTong University of medicine Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, 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, China
The Fourth Central Hospital of Tianjin
🇨🇳Tianjin, Tianjin, 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