9MW1911: Participants will receive IV 9MW1911 in each dose every 28 days.
Phase II placebo: Participants will receive IV placebo every 28 days.
Study summary
The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety of 9MW1911 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
\- 1.Male or Female patients must be 40 to 75 years of age inclusive; 2.Physician diagnosis of COPD for at least 1 year at screening; 3.Documented history of \>= 2 moderate or \>=1 severe COPD exacerbations within 12 months prior to screening.
4.Moderate-to-severe COPD with post-BD FEV1/FVC rato\<0.7 and a post-BD FEV1%predicted ≥20% and\<80% at screening; 5.Body Mass Index (BMI) of 16 kg/m² to 32 kg/m²; 6.Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years 7.Participants with standard of care controller therapy, for ≥3 months prior to Screening and at a stable dose of controller therapy for at least 1 month prior to the screening;
Exclusion Criteria:
* 1.Current diagnosis of asthma or documented history of asthma; 2.Diagnosis of Alpha-1 Antitrypsin Deficiency; 3.History of other clinically significant pulmonary diseases apart from COPD: such as sarcoidosis,interstitial lung diseases, bronchiectasis,cystic fibrosis,constrictive bronchiolitis,severe pulmonary hypertension or other active pulmonary diseases; 4.Long-term treatment with oxygen (oxygen therapy time \>15h/day) or mechanical ventilation, or clinically significant apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV); 5.History of lung pneumonectomy, or lung volume reduction within 12 months prior to screening,or planned to undergo lung volume reduction surgery (LVRS) during the study period; 6.Patients in the acute phase of pulmonary rehabilitation(participating in, or scheduled for a pulmonary rehabilitation program within 4 weeks of screening); 7.Uncured upper or lower respiratory tract infections during the screening period; 8.Moderate to severe COPD exacerbations within 4 weeks prior to screening or during the screening period; 9.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; 10.Received treatment with oral, IV, or intramuscular (IM) corticosteroids (\>10 mg/day prednisone or equivalent dose) within 4 weeks prior to starting study medication; 11.Myocardial infarction, unstable angina within 12 months prior to screening;or heart failure (NYHA Class III or IV) within 6 months prior to screening; 12.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 ), family history of unexplained sudden death or long QT syndrome; 13. experienced transient ischemic attack or stroke within 6 months prior to screening; 14.with unstable cardiovascular diseases, such as pulmonary embolism or deep vein thrombosis that occurred within 6 months before screening, which the researchers believe may put the patient at risk or have a negative impact on the research results; 15.Known active tuberculosis or nontuberculous mycobacterial infection (subjects with positive interferon - γ release assay (IGRA) during the screening period, if evaluated as inactive tuberculosis by the researcher based on clinical manifestations and imaging examinations, etc., can participate in this study); 16.Positive for human immunodeficiency virus antibody (HIV-Ab), or positive for hepatitis B surface antigen (HBsAg) with HBV-DNA copies \> 1000 IU/mL or above the upper limit of normal (ULN) of the study center, or positive for hepatitis C virus antibody (HCV-Ab) with HCV-RNA copies above the ULN of the study center, or positive for Treponema pallidum antibody.
17.With active autoimmune disease or receiving immunosuppressive therapy for an autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) are excluded.
18\. with any active malignancy or a history of malignancy (except for low-grade tumors deemed cured ≥5 years before screening, such as cervical carcinoma in situ or basal cell carcinoma).
19.received a live attenuated vaccine within 4 weeks prior to screening or during the screening period.
20.received any biologic therapy (e.g., omalizumab, dupilumab, and/or anti-interleukin-5 therapy) within 3 months prior to screening ; 21.received any investigational therapy within 3 months prior to screening or within 5 drug-elimination half-lives, whichever is longer.
22.Any clinically significant ECG abnormality deemed by the investigator to potentially affect study conduct, such as QTc prolongation (QTcF \> 450 ms for males, \> 470 ms for females).
23.Alanine aminotransferase (ALT) \>= 2 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) \>= 2 times ULN; Total bilirubin \>= 1.5 times ULN.
24.Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2. 25.with any serious medical condition or clinically significant laboratory abnormality(in investigator's judgment) that could compromise the subject's safety or ability to participate in or complete the study.
26\. With a history of alcohol abuse and/or substance abuse within 12 months prior to screening.
27.History of severe hypersensitivity or anaphylactic reactions to any biologic agent, or known hypersensitivity to any component of the investigational drug.
28\. Pregnant or lactating women, Or female paticipants of child-bearing potential with a positive pregnancy test at screening.
29.Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Primary outcome measure(s)
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) within 52 weeks — Baseline up to week 52 Within a 52-week period, the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is converted to an annual incidence rate.
Trial sites (51)
Facility
City
Region
Status
Chizhou Central Hospital
Chizhou
Anhui
Recruiting
Anhui Chest Hospital
Hefei
Anhui
Recruiting
Gansu Provincial People's Hospital
Lanzhou
Gansu
Recruiting
Huizhou Third People's Hospital
Huizhou
Guangdong
Recruiting
Jiangmen Central Hospital
Jiangmen
Guangdong
Recruiting
Qingyuan Hospital Affiliated to Guangzhou Medical University
Qingyuan
Guangdong
Recruiting
The Affiliated Hospital of Zunyi Medical University
Zunyi
Guizhou
Recruiting
Hebei PetroChina Central Hospital
Langfang
Hebei
Recruiting
The First Affiliated Hospital of Nanyang Medical College
Nanyang
Henan
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Henan
Recruiting
Xinxiang First People's Hospital
Xinxiang
Henan
Recruiting
Henan Provincial People's Hospital
Zhengzhou
Henan
Recruiting
Jingzhou First People's Hospital
Jinzhou
Hubei
Recruiting
Yichang Central People's Hospital
Yichang
Hubei
Recruiting
The Third Hospital of Changsha
Changsha
Hunan
Recruiting
The First Affiliated Hospital of University of South China
Hengyang
Hunan
Recruiting
Shaoyang Central Hospital
Shaoyang
Hunan
Recruiting
Xiangyang Central Hospital
Xiangyang
Hunan
Recruiting
Yongzhou Central Hospital
Yongzhou
Hunan
Recruiting
Yueyang Central Hospital
Yueyang
Hunan
Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
Affiliated Hospital of Yangzhou University
Yangzhou
Jiangsu
Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang
Jiangsu
Recruiting
Jiujiang First People's Hospital
Jiujiang
Jiangxi
Not Yet Recruiting
Jiangxi Provincial People's Hospital
Nanchang
Jiangxi
Recruiting
Pingxiang People's Hospital
Pingxiang
Jiangxi
Recruiting
Shengjing Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Inner Mongolia Baogang Hospital
Baotou
Neimenggu
Recruiting
Heze Municipal Hospital
Heze
Shandong
Recruiting
Shandong Provincial Hospital
Jinan
Shandong
Recruiting
Shandong Provincial Public Health Clinical Center
Jinan
Shandong
Recruiting
Weifang Second People's Hospital
Weifang
Shandong
Recruiting
Jinmei Group General Hospital
Jincheng
Shanxi
Recruiting
Shanxi Bethune Hospital
Taiyuan
Shanxi
Recruiting
Xi'an Chest Hospital
Xi’an
Shanxi
Recruiting
Chengdu Fifth People's Hospital
Chengdu
Sichuan
Recruiting
Yibin Second People's Hospital
Yibin
Sichuan
Recruiting
Yunnan Provincial First People's Hospital
Kunming
Yunnan
Recruiting
Huzhou Central Hospital
Huzhou
Zhejiang
Recruiting
Jiaxing First Hospital
Jiaxing
Zhejiang
Recruiting
+ 11 more sites — see the full list on the official registry below.
More Mabwell (Shanghai) Bioscience Co., Ltd. trials in China
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.
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