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

• Status: Completed
• Trial end date: 2016-11-25
• Target enrollment: 0
• Participant gender: All

Summary

Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal

Criteria

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