New drug aims to cut COPD attacks in half
NCT ID NCT07292714
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing an experimental drug called 9MW1911 in 360 adults with moderate-to-severe COPD who have had at least two flare-ups in the past year. Participants receive either the drug or a placebo every 28 days for a year. The main goal is to see if the drug reduces the number of serious flare-ups and improves breathing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 9MW1911 (an experimental drug given intravenously every 28 days)
- What this could lead to
- If it works, 9MW1911 could reduce the number of serious COPD flare-ups and improve lung function for people with moderate-to-severe COPD.
- What could go wrong
- This is a mid-stage trial with only 360 participants, so results may not apply to everyone. The drug is experimental and may not work better than placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
51 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Jiangsu University
RECRUITINGZhenjiang, Jiangsu, China
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Affiliated Hospital of Yangzhou University
RECRUITINGYangzhou, Jiangsu, China
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Anhui Chest Hospital
RECRUITINGHefei, Anhui, China
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Beijing Chaoyang Hospital
RECRUITINGBeijing, China
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Beijing Luhe Hospital
RECRUITINGBeijing, China
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Chengdu Fifth People's Hospital
RECRUITINGChengdu, Sichuan, China
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Chizhou Central Hospital
RECRUITINGChizhou, Anhui, China
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Chongming Hospital Affiliated to Shanghai University of Medicine & Health Sciences
RECRUITINGShanghai, China
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Chongqing jiangjin hospital
RECRUITINGChongqing, China
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Gansu Provincial People's Hospital
RECRUITINGLanzhou, Gansu, China
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Hebei PetroChina Central Hospital
RECRUITINGLangfang, Hebei, China
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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, China
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Heze Municipal Hospital
RECRUITINGHeze, Shandong, China
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Huizhou Third People's Hospital
RECRUITINGHuizhou, Guangdong, China
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Huzhou Central Hospital
RECRUITINGHuzhou, Zhejiang, China
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Inner Mongolia Autonomous Region People's Hospital
RECRUITINGNeimeng, China
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Inner Mongolia Baogang Hospital
RECRUITINGBaotou, Neimenggu, China
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Jiangmen Central Hospital
RECRUITINGJiangmen, Guangdong, China
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Jiangxi Provincial People's Hospital
RECRUITINGNanchang, Jiangxi, China
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Jiaxing First Hospital
RECRUITINGJiaxing, Zhejiang, China
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Jingzhou First People's Hospital
RECRUITINGJinzhou, Hubei, China
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Jinmei Group General Hospital
RECRUITINGJincheng, Shanxi, China
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Jiujiang First People's Hospital
NOT_YET_RECRUITINGJiujiang, Jiangxi, China
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Peking University Third Hospital
RECRUITINGBeijing, China
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Pingxiang People's Hospital
RECRUITINGPingxiang, Jiangxi, China
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Qingyuan Hospital Affiliated to Guangzhou Medical University
RECRUITINGQingyuan, Guangdong, China
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Shandong Provincial Hospital
RECRUITINGJinan, Shandong, China
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Shandong Provincial Public Health Clinical Center
RECRUITINGJinan, Shandong, China
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Shanghai Fifth People's Hospital
RECRUITINGShanghai, China
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, China
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Shanxi Bethune Hospital
RECRUITINGTaiyuan, Shanxi, China
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Shaoyang Central Hospital
RECRUITINGShaoyang, Hunan, China
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Shengjing Hospital of China Medical University
RECRUITINGShenyang, Liaoning, China
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Taizhou Hospital of Zhejiang Province
RECRUITINGTaizhou, Zhejiang, China
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The Affiliated Hospital of Xuzhou Medical University
RECRUITINGXuzhou, Jiangsu, China
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The Affiliated Hospital of Zunyi Medical University
RECRUITINGZunyi, Guizhou, China
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The First Affiliated Hospital of Nanyang Medical College
RECRUITINGNanyang, Henan, China
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The First Affiliated Hospital of University of South China
RECRUITINGHengyang, Hunan, China
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The First Affiliated Hospital of Xinxiang Medical University
RECRUITINGXinxiang, Henan, China
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The Second Affiliated Hospital of Chongqing Medical University
RECRUITINGChongqing, China
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The Third Hospital of Changsha
RECRUITINGChangsha, Hunan, China
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Weifang Second People's Hospital
RECRUITINGWeifang, Shandong, China
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Xi'an Chest Hospital
RECRUITINGXi’an, Shanxi, China
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Xiangyang Central Hospital
RECRUITINGXiangyang, Hunan, China
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Xinxiang First People's Hospital
RECRUITINGXinxiang, Henan, China
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Yibin Second People's Hospital
RECRUITINGYibin, Sichuan, China
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Yichang Central People's Hospital
RECRUITINGYichang, Hubei, China
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Yichang Central People's Hospital
RECRUITINGYichang, China
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Yongzhou Central Hospital
RECRUITINGYongzhou, Hunan, China
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Yueyang Central Hospital
RECRUITINGYueyang, Hunan, China
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Yunnan Provincial First People's Hospital
RECRUITINGKunming, Yunnan, China
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Other studies related to the condition(s) this trial covers.
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