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

NCT02546700

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Lebrikizumab, Placebo

Countries: United States, Argentina, Bulgaria, Canada, Denmark, Hungary, Mexico, Poland

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (66)
  • Birmingham, Alabama, United States
  • Peoria, Arizona, United States
  • Northridge, California, United States
  • Palm Springs, California, United States
  • Miami, Florida, United States
  • Port Orange, Florida, United States
  • Columbus, Georgia, United States
  • Savannah, Georgia, United States
  • Lake Charles, Louisiana, United States
  • St Louis, Missouri, United States
  • Berlin, New Jersey, United States
  • Jamaica, New York, United States
  • Gastonia, North Carolina, United States
  • Medford, Oregon, United States
  • Old Point Station, South Carolina, United States
  • Spartanburg, South Carolina, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Everett, Washington, United States
  • Spokane, Washington, United States
  • Tacoma, Washington, United States
  • Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Quilmes, Argentina
  • San Miguel de Tucumán, Argentina
  • Santa Fe, Argentina
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • + 36 more on CT.gov