9MW1911 for adults with 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)

This trial will test whether the investigational drug 9MW1911 can reduce flare-ups and improve breathing in adults aged 40–75 with moderate-to-severe COPD and recent exacerbations.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Drugs / interventions: omalizumab, dupilumab, prednisone
• Locations: 51 sites (Chizhou, Anhui and 50 other locations)
• Trial ID: NCT07292714 on ClinicalTrials.gov

What this trial studies

This is a Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled trial of 9MW1911 in patients with COPD. Eligible participants are adults 40–75 with a physician diagnosis of COPD for at least one year, a history of frequent exacerbations in the prior 12 months, post-bronchodilator FEV1/FVC < 0.70 and FEV1 20–80% predicted, and who are on stable controller therapy. Key exclusions include current or past asthma, alpha-1 antitrypsin deficiency, and other significant non-COPD lung diseases. The study is being conducted at multiple hospitals in China and compares 9MW1911 to placebo while participants remain on standard-of-care therapy.

Who should consider this trial

Good fit: Adults aged 40 to 75 with moderate-to-severe COPD, a documented history of recent exacerbations, post-BD FEV1/FVC < 0.7 and FEV1 between 20% and 80% predicted, and on stable controller therapy may be eligible.

Not a fit: Patients with current or prior asthma, alpha-1 antitrypsin deficiency, or other clinically significant non-COPD pulmonary diseases are excluded and would not be expected to benefit from this study drug.

Why it matters

Potential benefit: If successful, 9MW1911 could reduce COPD exacerbations and improve symptoms and quality of life for people with frequent flare-ups.

How similar studies have performed: Other randomized, placebo-controlled Phase II studies of novel COPD therapies have shown mixed results, and 9MW1911 has not yet been proven effective in late-stage clinical trials.

Eligibility criteria

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.

Where this trial is running

Chizhou, Anhui and 50 other locations

• Chizhou Central Hospital — Chizhou, Anhui, China (Recruiting)
• Anhui Chest Hospital — Hefei, Anhui, China (Recruiting)
• Gansu Provincial People's Hospital — Lanzhou, Gansu, China (Recruiting)
• Huizhou Third People's Hospital — Huizhou, Guangdong, China (Recruiting)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Recruiting)
• Qingyuan Hospital Affiliated to Guangzhou Medical University — Qingyuan, Guangdong, China (Recruiting)
• The Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
• Hebei PetroChina Central Hospital — Langfang, Hebei, China (Recruiting)
• The First Affiliated Hospital of Nanyang Medical College — Nanyang, Henan, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (Recruiting)
• Xinxiang First People's Hospital — Xinxiang, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Jingzhou First People's Hospital — Jinzhou, Hubei, China (Recruiting)
• Yichang Central People's Hospital — Yichang, Hubei, China (Recruiting)
• The Third Hospital of Changsha — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
• Shaoyang Central Hospital — Shaoyang, Hunan, China (Recruiting)
• Xiangyang Central Hospital — Xiangyang, Hunan, China (Recruiting)
• Yongzhou Central Hospital — Yongzhou, Hunan, China (Recruiting)
• Yueyang Central Hospital — Yueyang, Hunan, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Affiliated Hospital of Yangzhou University — Yangzhou, Jiangsu, China (Recruiting)
• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Recruiting)
• Jiujiang First People's Hospital — Jiujiang, Jiangxi, China (Not_yet_recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Recruiting)
• Pingxiang People's Hospital — Pingxiang, Jiangxi, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Inner Mongolia Baogang Hospital — Baotou, Neimenggu, China (Recruiting)
• Heze Municipal Hospital — Heze, Shandong, China (Recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
• Shandong Provincial Public Health Clinical Center — Jinan, Shandong, China (Recruiting)
• Weifang Second People's Hospital — Weifang, Shandong, China (Recruiting)
• Jinmei Group General Hospital — Jincheng, Shanxi, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• Xi'an Chest Hospital — Xi’an, Shanxi, China (Recruiting)
• Chengdu Fifth People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Yibin Second People's Hospital — Yibin, Sichuan, China (Recruiting)
• Yunnan Provincial First People's Hospital — Kunming, Yunnan, China (Recruiting)
• Huzhou Central Hospital — Huzhou, Zhejiang, China (Recruiting)
• Jiaxing First Hospital — Jiaxing, Zhejiang, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)
• Beijing Chaoyang Hospital — Beijing, China (Recruiting)
• Beijing Luhe Hospital — Beijing, China (Recruiting)
• Peking University Third Hospital — Beijing, China (Recruiting)
• Chongqing jiangjin hospital — Chongqing, China (Recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
• Inner Mongolia Autonomous Region People's Hospital — Neimeng, China (Recruiting)
• Chongming Hospital Affiliated to Shanghai University of Medicine & Health Sciences — Shanghai, China (Recruiting)
• Shanghai Fifth People's Hospital — Shanghai, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yongchang Sun, Doctor

Conditions Chronic Obstructive Pulmonary Disease COPD