A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT07292714
Last Updated: 2025-12-18
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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RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2025-07-15
2028-02-29
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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Phase II 9MW1911
9MW1911 is administered intravenously in two dose levels. Each dose group include 120 patients.
9MW1911
Participants will receive IV 9MW1911 in each dose every 28 days.
Phase II Placebo
Phase II Placebo is administered intravenously. this group includes 120 patients.
Phase II placebo
Participants will receive IV placebo every 28 days.
Interventions
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9MW1911
Participants will receive IV 9MW1911 in each dose every 28 days.
Phase II placebo
Participants will receive IV placebo every 28 days.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
75 Years
ALL
No
Sponsors
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Mabwell (Shanghai) Bioscience Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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9MW1911-2025-CP201
Identifier Type: -
Identifier Source: org_study_id