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The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic characteristics of TQC2938 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is anticipated that 256 subjects will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC2938 injection | Experimental | TQC2938 injection is injected subcutaneously every 28 days for a treatment cycle of 52 weeks. |
|
| TQC2938 injection Placebo | Placebo Comparator | Subcutaneous injection of 0 mg TQC2938 injection solution, with a treatment cycle of every 28 days, for a total of 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC2938 injection | Drug | TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD within 24 weeks | Within a 24-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate. | Baseline up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessment | The incidence and severity of adverse events, adverse reactions, serious adverse events, as well as abnormal clinical laboratory test indicators, vital signs, physical examinations, and 12-lead electrocardiograms. | Baseline up to week 64 |
| Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An Hui Chest Hospital | Hefei | Anhui | 230000 | China | ||
| China-Japan Friendship Hospital |
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| TQC2938 injection Placebo | Drug | TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade. |
|
Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate. |
| Baseline up to week 52 |
| The change in trough volume of forceful exhalation in the first second (FEV1) (pre-bronchodilator) from baseline after 24 weeks | Comparing the difference between the highest FEV1 values at 24 weeks and at baseline for the subjects. | Baseline up to week 24 |
| The change in trough FEV1 (pre-bronchodilator) from baseline after 52weeks | Comparing the difference between the lowest FEV1 values at 52 weeks and the lowest FEV1 values at baseline for the subjects. | Baseline up to week 52 |
| The change in FEV1 from baseline after 52 weeks of bronchodilator use | The change in FEV1 from baseline after 52 weeks of bronchodilator use | Baseline up to week 52 |
| The annualized incidence rate of severe AECOPD within 52 weeks | Within a 52-week period, the number of severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate. | Baseline up to week 52 |
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Peolpe's Hospital Of Chongqing Banan District | Chongqing | Chongqing Municipality | 400054 | China |
| Shunde Hospital Of Southern Medical University | Foshan | Guangdong | 528308 | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | 529000 | China |
| Liuzhou municipal liutie central hospital | Liuzhou | Guangxi | 545007 | China |
| The First People' Hospital Of YuLin | Yulin | Guangxi | 537000 | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | 061000 | China |
| Xingtai People's Hospital | Xingtai | Hebei | 54000 | China |
| The second hospital of hebei medical university | Shijiazhuang | Heibei | 05000 | China |
| The First Affiliated Hospital of Jiamusi University | Jiamusi | Heilongjiang | 154003 | China |
| The First Hospital of Qiqihar | Qiqihar | Heilongjiang | 161005 | China |
| Puyang Oilfield General Hospital | Puyang | Henan | 457001 | China |
| The First People's Hospital of Xinxiang City | Xinxiang | Henan | 453000 | China |
| Yongcheng People's Hospital | Yongcheng | Henan | 476600 | China |
| Henan Chest Hospital | Zhengzhou | Henan | 450000 | China |
| The second xiangya hospital of central south university | Changsha | Hunan | 410011 | China |
| Shaoyang Central Hospital | Shaoyang | Hunan | 422000 | China |
| The Affiliated Hospital of Mongolia Medical College | Hohhot | Inner Mongolia | 010000 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212050 | China |
| Jiangxi Provincal People's Hospital | Nanchang | Jiangxi | 330000 | China |
| Meihekou Central Hospital | Meihekou | Jilin | 135000 | China |
| Siping Central People's Hospital | Siping | Jilin | 136099 | China |
| Heze Municipal Hospital | Heze | Shandong | China |
| Weifang NO.2 People' Hospital | Weifang | Shandong | 261041 | China |
| Shanghai JiaoTong University of medicine Ruijin Hospital | Shanghai | Shanghai Municipality | 20025 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Linfen Central Hospital | Linfen | Shanxi | 041099 | China |
| Xi'An International Medicl Center Hospital | Xi’an | Shanxi | 710061 | China |
| Affiliated Hospital Of ChengDu University | Chengdu | Sichuan | 610081 | China |
| Leshan People's Hospital | Leshan | Sichuan | 614099 | China |
| Suining Central Hospital | Suining | Sichuan | 629000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300041 | China |
| The Fourth Central Hospital of Tianjin | Tianjin | Tianjin Municipality | 300140 | China |
| The Third People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | 830091 | China |
| Jinhua Municipal Centeral Hospital Medical Group | Jinhua | Zhejiang | 321000 | China |
| The First Affiliated Hospitial Of Ningbo University | Ningbo | Zhejiang | 315211 | China |
| Taizhou Hospital Of Zhejiang Province | Taizhou | Zhejiang | 318000 | China |
| The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU | Wenzhou | Zhejiang | 325027 | China |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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