🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07292714
Recruiting Phase 2

A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT07292714 · tracked via the Priya Life Science China tracker
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Phase
Phase 2
Started
2025-07-15
Last updated
2025-12-18

Condition(s) studied

Chronic Obstructive Pulmonary Disease COPD

Investigational drug(s) / intervention(s)

9MW1911Phase II placebo

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)

Trial sites (51)

FacilityCityRegionStatus
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

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 NCT07292714 on ClinicalTrials.gov ↗ ← All trials in China