A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Read More

Inclusion Criteria:

• Documented history of COPD greater than or equal to (>/=) 12 months prior to Visit 1
• Post-bronchodilator FEV1/FVC less than (<) 0.70 at Visit 1 or 2
• Post bronchodilator FEV1 <80% predicted at Visit 1 or 2
• Documented history of one or more acute COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1
• Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking >/=10 pack-years (20 cigarettes/day for 10 years)
• On inhaled corticosteroids (ICS) therapy for >/=6 months prior to Visit 1
• On an eligible bronchodilator medication for >/=6 months prior to Visit 1
• Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray prior to Visit 2 that confirms absence of clinically significant lung disease besides COPD
• Demonstrated adherence with background COPD inhaler medication during screening period
• For female participants of childbearing age, use of single or combined contraceptive methods for the duration of the study

Exclusion Criteria:

• History of severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to lebrikizumab injection
• History of clinically significant pulmonary disease other than COPD
• Diagnosis of alpha-1-antitrypsin deficiency
• Lung volume reduction surgery or procedure within 12 months prior to Visit 1
• Supplemental oxygen requirement >2 liters/minute (L/min) at rest or with exertion
• Current diagnosis of asthma
• Participants participating in, or scheduled for, an intensive COPD rehabilitation program
• Maintenance oral corticosteroid therapy
• Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during screen period
• Unstable ischemic heart disease or other relevant cardiovascular disorders
• Use of an immunomodulatory or immunosuppressive therapy including monoclonal antibodies (includes anti-interleukin-13 (IL) or anti-IL-4/IL-13 therapy)
• Body weight <40 kg
• Any infection that resulted in hospital admission for >/= 24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
• Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
• Active parasitic or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
• Received a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening
• Active tuberculosis requiring treatment within 12 months prior to Visit 1
• Human immunodeficiency virus (HIV) or other known immunodeficiency
• Hepatitis or known liver cirrhosis
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ATL), or total bilirubin elevation >/=2.0 x upper limit of normal (ULN) during screening
• Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests
• History of alcohol or drug abuse
• Pregnant or lactating