A Clinical Study to Evaluate the Efficacy and Safety of TQC2938 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT06789289
Last Updated: 2025-01-23
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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NOT_YET_RECRUITING
PHASE2
256 participants
INTERVENTIONAL
2025-04-30
2027-12-31
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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TQC2938 injection
TQC2938 injection is injected subcutaneously every 28 days for a treatment cycle of 52 weeks.
TQC2938 injection
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 injection Placebo
Subcutaneous injection of 0 mg TQC2938 injection solution, with a treatment cycle of every 28 days, for a total of 52 weeks.
TQC2938 injection Placebo
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
Interventions
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TQC2938 injection
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
TQC2938 injection Placebo
TQC2938 is a humanized monoclonal antibody that interfering with the signal cascade.
Eligibility Criteria
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Inclusion Criteria
* Be aged 40-80 years inclusive at the time of signing the informed consent form；
* Have a record of COPD diagnosis for at least 12 months prior to screening；
* At screening or after bronchodilator use at the time of the first dose, FEV1 is ≥20% but \<80% of the predicted value；
* The FEV1/forced vital capacity (FVC) ratio, measured after the use of bronchodilators at screening or at the time of the first dose, is less than 0.70；
* At screening, the Modified Medical Research Council (mMRC) score is ≥2；
* At screening, the CAT≥10；
* Current smokers or former smokers (who have quit smoking for at least 6 months before Visit 1) with a smoking history of ≥10 pack-years (for example: 20 cigarettes/day for 10 years). At screening, subjects who meet the definition of current smokers will be referred to a smoking cessation clinic；
* A chest X-ray or computed tomography (CT) scan within the 3 months prior to screening or during the screening period (before the first dose of study medication) confirms that there are no other clinically significant pulmonary diseases present apart from COPD.
Exclusion Criteria
* Current or past confirmed diagnosis of asthma;
* History of other clinically significant pulmonary diseases apart from COPD: such as lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung diseases, cystic fibrosis, constrictive bronchiolitis, tuberculosis, or other active pulmonary diseases;
* Evidence of cor pulmonale with right heart failure；
* Diagnosed with α-1-antitrypsin deficiency;
* History of long-term oxygen therapy with \>4 L/min;
* When using respiratory assistive oxygen, the subject's oxygen saturation should be ≥89%;
* Undergone lung volume reduction surgery or procedures within the 12 months prior to screening;
* Subjects participating or planning to participate in an intensive COPD rehabilitation program (subjects in the maintenance phase of a rehabilitation program are eligible for this study);
* History of lung transplantation;
* Any infection requiring hospitalization for ≥24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to screening or during the screening period;
* Upper or lower respiratory tract infections requiring antibiotic or antiviral medication within 4 weeks prior to screening or during the screening period;
* Moderate to severe COPD exacerbations within 4 weeks prior to screening or during the screening period.
* Received treatment with oral, IV, or intramuscular (IM) corticosteroids (\>10 mg/day prednisone or equivalent dose) within 4 weeks prior to starting study medication;
* Received treatment with clinical trial medication, approved biologics (e.g., omalizumab, dupilumab, and/or anti-Interleukin 5 (IL-5) therapies) within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer), or started or changed non-biologic immunomodulatory or immunosuppressive therapies;
* Receiving palliative care due to chronic respiratory disease, cardiovascular disease, endocrine and other systemic diseases, or cancer (e.g., for subjects with a life expectancy \<12 months);
* Undergone major surgery within 8 weeks prior to screening or planning to undergo surgery that requires general anesthesia or hospitalization \>1 day during the study period;
* Received or planning to receive live attenuated vaccine within 4 weeks prior to screening, during the screening period, or during the study period;
* Known immune deficiency, including but not limited to HIV infection;
* Elevated Aspartate Aminotransferase (AST), Alanine transaminase (ALT), or total bilirubin ≥2.0× the upper limit of normal (ULN) during the screening period;
* At screening, presence of any of the following: positive for hepatitis B surface antigen (HBsAg), positive for both hepatitis C virus antibody (HCV Ab) and hepatitis C virus RNA (HCV-RNA), positive for both specific and non-specific antibodies for syphilis (TP Ab);
* As determined by the investigator, history of illicit drug or drug abuse within the 12 months prior to screening;
* History of malignancy within 5 years prior to screening, except for those with negligible risk of metastasis or death (e.g., with a 5-year overall survival rate \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ;
* Presence of any other serious disease or abnormal clinical laboratory test results that, in the opinion of the investigator, would prevent the subject from safely participating in or completing the study；
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening;
* History or current presence of clinically significant ECG abnormalities, as determined by the investigator, including but not limited to: (1) Atrial fibrillation (AF) with a rapid ventricular rate \>120 bpm; (2) Sustained ventricular tachycardia (VT); (3) Bradycardia with a ventricular rate \<45 bpm; (4) Mobitz Type II second-degree atrioventricular block and third-degree atrioventricular block (unless a pacemaker or defibrillator has been implanted);
* Corrected QT interval (QTcF) \>450 ms for male subjects or \>470 ms for female subjects; for subjects with Q wave, R wave, and S wave (QRS) \>120 ms, QTcF \>480 ms；
* History of ventricular arrhythmias or risk factors for ventricular arrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, severe left ventricular hypertrophy with fibrosis), family history of unexplained sudden death or long QT syndrome, or history of sinus bradycardia (ventricular rate \<45 beats/min);
* Pregnant or breastfeeding, or planning to become pregnant during the study period or within 12 weeks after the last dose of TQC2938, or female subjects with a positive pregnancy test at screening or randomization.
40 Years
80 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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An Hui Chest Hospital
Hefei, Anhui, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, China
Shunde Hospital Of Southern Medical University
Foshan, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Liuzhou municipal liutie central hospital
Liuzhou, Guangxi, China
The First People' Hospital Of YuLin
Yulin, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The second hospital of hebei medical university
Shijiazhuang, Heibei, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, China
Puyang Oilfield General Hospital
Puyang, Henan, China
The First People's Hospital of Xinxiang City
Xinxiang, Henan, China
Yongcheng People's Hospital
Yongcheng, Henan, China
Henan Chest Hospital
Zhengzhou, Henan, China
The second xiangya hospital of central south university
Changsha, Hunan, China
Shaoyang Central Hospital
Shaoyang, Hunan, China
The Affiliated Hospital of Mongolia Medical College
Hohhot, Inner Mongolia, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, China
Meihekou Central Hospital
Meihekou, Jilin, China
Siping Central People's Hospital
Siping, Jilin, China
Heze Municipal Hospital
Heze, Shandong, China
Weifang NO.2 People' Hospital
Weifang, Shandong, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
Xi'An International Medicl Center Hospital
Xi’an, Shanxi, China
Affiliated Hospital Of ChengDu University
Chengdu, Sichuan, China
Leshan People's Hospital
Leshan, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, China
The Third People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang, China
The First Affiliated Hospitial Of Ningbo University
Ningbo, Zhejiang, China
Taizhou Hospital Of Zhejiang Province
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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Central Contacts
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Facility Contacts
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Other Identifiers
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TQC2938-II-01
Identifier Type: -
Identifier Source: org_study_id
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