Phase
Condition
N/ATreatment
Placebo
9MW1911
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 with ascore >=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 12 monthsprior 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 prior toscreening;
- 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 Human ImmunodeficiencyVirus (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 could affectthe result of this study.
- Pregnant or lactating women. Women of child-bearing potential (WOCBP) with a positiveblood serum pregnancy test at screening. Planning a pregnancy during the interventionperiod and for at least 20 weeks after the last dose of study intervention. Subjectsof child-bearing potential (including female subjects, male subjects and their femalepartners of child-bearing potential) unable to use reliable contraception during theintervention period and for at least 20 weeks after the last dose of studyintervention.
- Confirmed COVID-19 infection at screening. Known history of COVID-19 infection within 4 weeks prior to screening. History of requiring mechanical ventilation orextracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months priorto screening. Participants who have had a COVID-19 infection prior screening have notyet sufficiently recovered to participate in the procedures of a clinical trial.
- 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,
ChinaActive - Recruiting
China-Japan Friendship Hospital
Beijing,
ChinaActive - Recruiting
Peking University Shougang Hospital
Beijing,
ChinaActive - Recruiting
The First Hospital of Changsha
Changsha,
ChinaActive - Recruiting
The second xiangya hospital of central south university
Changsha,
ChinaActive - Recruiting
Chengdu Fifth People's Hospital
Chengdu,
ChinaActive - Recruiting
Chongqing Red Cross Hospital (People's Hospital of Jiangbei District)
Chongqing,
ChinaActive - Recruiting
Fu Yang People's Hospital
Fuyang,
ChinaActive - Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaActive - Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou,
ChinaActive - Recruiting
The Second Hospital, University of South China
Hengyang,
ChinaActive - Recruiting
The Third People's Hospital of Huizhou
Huizhou,
ChinaActive - Recruiting
Jiangmen Central Hospital
Jiangmen,
ChinaActive - Recruiting
Liaocheng People's Hospital
Liaocheng,
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang,
ChinaActive - Recruiting
Pingxiang People's Hospital
Pingxiang,
ChinaActive - Recruiting
The First Affiliated Hospital of Qiqihar Medical University
Qiqihar,
ChinaActive - Recruiting
Tongji Hospital of Tongji University
Shanghai,
ChinaActive - Recruiting
Shengjing Hospital of China Medical University
Shenyang,
ChinaActive - Recruiting
Suzhou Municipal Hospital
Suzhou,
ChinaActive - Recruiting
The First Hospital of Shanxi Medical University
Taiyuan,
ChinaActive - Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou,
ChinaActive - Recruiting
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