Overview
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
Eligibility
Inclusion Criteria
- Documented COPD diagnosis for ≥ 12 months
- History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
- Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening
- Post-bronchodilator FEV1/FVC < 0.70 at screening
- Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
- Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
- On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
- Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
Exclusion Criteria
- Current documented diagnosis of asthma
- History of clinically significant pulmonary disease other than COPD
- Diagnosis of 1-antitrypsin deficiency
- History of long-term treatment with oxygen at > 4.0 liters/minute
- Lung volume reduction surgery or procedure within 12 months prior to screening
- Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
- History of lung transplant
- Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
- Upper or lower respiratory tract infection within 4 weeks prior to or during screening
- Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
- Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
- Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening