Phase
Condition
N/ATreatment
9MW1911
Placebo
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients must be >=40 years of age and capable of giving signedinformed consent.
Body Mass Index (BMI) of 16 kg/m² to 32 kg/m².
Documented physician diagnosis of COPD for at least 1 year.
Smoking history with a minimum of 10 pack-year.
Post-bronchodilator of FEV1>=30 and <80% of predicted normal value at screening.
Modified Medical Research Council (dyspnea scale) (mMRC) score>=2.
COPD assessment score (CAT) score >=10, with each of the phlegm and cough items witha score >=2.
Documented stable, standard-of-care COPD maintenance therapy for at least 8 weeksprior to screening, with no anticipated changes during the screening period andthroughout the study.
Documented history of >= 2 moderate or >=1 severe COPD exacerbations within 12months prior to screening.
Exclusion
Exclusion Criteria:
Current diagnosis of asthma according to the Global Initiative for Asthma guidelinesor other accepted guidelines, or documented history of asthma.
Diagnosis of Alpha-1 Antitrypsin Deficiency.
Moderate to severe COPD exacerbation, within 4 weeks prior to randomization.
History of lung pneumonectomy, or lung volume reduction within 12 months prior toscreening.
Clinically significant respiratory disease other than COPD that significantly affectthe study.
Evidence of active injection with Mycobacterium tuberculosis or nontuberculousmycobacteria, latent, or inadequately treated infection with Mycobacteriumtuberculosis.
COVID-19 vaccination injection within 14 days before randomization.
Long-term treatment with oxygen (oxygen therapy time >15h/day), or treatment withmechanical ventilation
Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).
Participating in, or scheduled for a pulmonary rehabilitation program within 4 weeksof screening.
Clinically significant abnormal electrocardiogram (ECG) at randomization that mayaffect the conduct of the study.
Myocardial infarction, unstable angina, or stroke occurring within 12 months priorto screening;
Heart failure (NYHA Class III or IV) within 6 months prior to screening.
Uncontrolled hypertension (ie, systolic blood pressure>180 mmHg or diastolic bloodpressure >110 mmHg with or without use of anti-hypertensive therapy).
Treatment with other biological agents (including anti-IL4, IL-5, IL-13 monoclonalantibodies) or immunosuppressive therapy within 2 months prior to screening.
Alcohol or drug abuse within 1 year prior to screening.
Malignancy, current or within the past 5 years. Suspected malignancy or undefinedneoplasms.
Positive test for Hepatitis B surface antigen (HbsAg), Hepatitis C virus antibody (HCVAb), Syphilis Treponema pallidum antibody (Syphilis TP), or HumanImmunodeficiency Virus (HIV Ag/Ab).
Alanine aminotransferase (ALT) >= 2 times the upper limit of normal (ULN); Aspartateaminotransferase (AST) >= 2 times ULN; Total bilirubin >= 1.5 times ULN.
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2.
History of systemic allergic reaction (including systemic allergic reaction to anybiological therapy), or history of immediate allergic reaction to any biologicaltherapy.
Participation in an interventional clinical studies within 3 months that couldaffect the result of this study.
Pregnant or lactating women. Women of child-bearing potential (WOCBP) with apositive blood serum pregnancy test at screening. Planning a pregnancy during theintervention period and for at least 20 weeks after the last dose of studyintervention. Subjects of child-bearing potential (including female subjects, malesubjects and their female partners of child-bearing potential) unable to usereliable contraception during the intervention period and for at least 20 weeksafter the last dose of study intervention.
Confirmed COVID-19 infection at screening. Known history of COVID-19 infectionwithin 4 weeks prior to screening. History of requiring mechanical ventilation orextracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 monthsprior to screening. Participants who have had a COVID-19 infection prior screeninghave not yet sufficiently recovered to participate in the procedures of a clinicaltrial.
Life expectancy of no more than 12 months.
Subjects who is inappropriate to participate in the trial due to any reasons asdetermined by the investigator.
Study Design
Connect with a study center
Baogang Hospital (No 3 Hospital Affiliated to Medical College of Inner Mongolia)
Baotou,
ChinaSite Not Available
China-Japan Friendship Hospital
Beijing,
ChinaSite Not Available
Peking University Shougang Hospital
Beijing,
ChinaSite Not Available
The First Hospital of Changsha
Changsha,
ChinaSite Not Available
The second xiangya hospital of central south university
Changsha,
ChinaSite Not Available
Chengdu Fifth People's Hospital
Chengdu,
ChinaSite Not Available
Chongqing Red Cross Hospital (People's Hospital of Jiangbei District)
Chongqing,
ChinaSite Not Available
Fu Yang People's Hospital
Fuyang,
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaSite Not Available
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaSite Not Available
The Second Hospital, University of South China
Hengyang,
ChinaSite Not Available
The Third People's Hospital of Huizhou
Huizhou,
ChinaSite Not Available
Jiangmen Central Hospital
Jiangmen,
ChinaSite Not Available
Liaocheng People's Hospital
Liaocheng,
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
Pingxiang People's Hospital
Pingxiang,
ChinaSite Not Available
The First Affiliated Hospital of Qiqihar Medical University
Qiqihar,
ChinaSite Not Available
Tongji Hospital of Tongji University
Shanghai,
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang,
ChinaSite Not Available
Suzhou Municipal Hospital
Suzhou,
ChinaSite Not Available
The First Hospital of Shanxi Medical University
Taiyuan,
ChinaSite Not Available
Taizhou Hospital of Zhejiang Province
Taizhou,
ChinaSite Not Available
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