A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate Efficacy and Safety of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
360
1 country
51
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2025
CompletedFirst Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
December 18, 2025
December 1, 2025
2.4 years
December 2, 2025
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The annualized incidence rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD） within 52 weeks
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
Secondary Outcomes (15)
Changes from baseline in pre-bronchodilator FEV1
Weeks 0, 4, 8, 12,24,36,52
Changes from baseline in post-bronchodilator FEV1
Weeks 0, 4, 8, 12,24,36,52
Changes from baseline in pre-bronchodilator FVC
Weeks 0, 4, 8, 12,24,36,52
Changes from baseline in post-bronchodilator FVC
Weeks 0, 4, 8, 12,24,36,52
Time to first moderate to severe Chronic Obstructive Pulmonary Disease Acute Exacerbation (AECOPD) from baseline to week 52.
Baseline to week 52
- +10 more secondary outcomes
Study Arms (2)
Phase II 9MW1911
EXPERIMENTAL9MW1911 is administered intravenously in two dose levels. Each dose group include 120 patients.
Phase II Placebo
PLACEBO COMPARATORPhase II Placebo is administered intravenously. this group includes 120 patients.
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
- 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；
You may not qualify if:
- 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.
- 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.
- \. 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).
- received a live attenuated vaccine within 4 weeks prior to screening or during the screening period.
- 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.
- 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).
- Alanine aminotransferase (ALT) \>= 2 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) \>= 2 times ULN; Total bilirubin \>= 1.5 times ULN.
- 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.
- \. With a history of alcohol abuse and/or substance abuse within 12 months prior to screening.
- History of severe hypersensitivity or anaphylactic reactions to any biologic agent, or known hypersensitivity to any component of the investigational drug.
- \. Pregnant or lactating women, Or female paticipants of child-bearing potential with a positive pregnancy test at screening.
- Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Chizhou Central Hospital
Chizhou, Anhui, China
Anhui Chest Hospital
Hefei, Anhui, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, China
Huizhou Third People's Hospital
Huizhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Qingyuan Hospital Affiliated to Guangzhou Medical University
Qingyuan, Guangdong, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Hebei PetroChina Central Hospital
Langfang, Hebei, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Xinxiang First People's Hospital
Xinxiang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Jingzhou First People's Hospital
Jinzhou, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The Third Hospital of Changsha
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Shaoyang Central Hospital
Shaoyang, Hunan, China
Xiangyang Central Hospital
Xiangyang, Hunan, China
Yongzhou Central Hospital
Yongzhou, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Inner Mongolia Baogang Hospital
Baotou, Neimenggu, China
Heze Municipal Hospital
Heze, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China
Weifang Second People's Hospital
Weifang, Shandong, China
Jinmei Group General Hospital
Jincheng, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Xi'an Chest Hospital
Xi’an, Shanxi, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Yunnan Provincial First People's Hospital
Kunming, Yunnan, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Beijing Chaoyang Hospital
Beijing, China
Beijing Luhe Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Chongqing jiangjin hospital
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Inner Mongolia Autonomous Region People's Hospital
Neimeng, China
Chongming Hospital Affiliated to Shanghai University of Medicine & Health Sciences
Shanghai, China
Shanghai Fifth People's Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Yichang Central People's Hospital
Yichang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 18, 2025
Study Start
July 15, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share