A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Korábbi kezelés

• History of long-term treatment with oxygen at > 4.0 liters/minute
• Lung volume reduction surgery or procedure within 12 months prior to screening
• 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

Más betegség

• History of clinically significant pulmonary disease other than COPD
• History of lung transplant

Egyéb

• Current documented diagnosis of asthma
• Diagnosis of 1-antitrypsin deficiency
• Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)

• 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