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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT02546700

Run by

Hoffmann-La Roche

People needed

309

Starts

2015-09-30

Expected to finish

2016-11-25

Last updated by the study team

2017-09-06

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC — Peoria, Arizona, United States
• California Medical Research Associates, Inc. — Northridge, California, United States
• Palmtree Clinical research Inc — Palm Springs, California, United States
• Finlay Medical Research — Miami, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Southeast Regional Res Group — Savannah, Georgia, United States
• Centex Studies — Lake Charles, Louisiana, United States
• The Clinical Research Ctr — St Louis, Missouri, United States
• Comprehensive Clinical Research Inc. — Berlin, New Jersey, United States
• ISA Clinical Research — Jamaica, New York, United States
• Gastonia Pharmaceutical Research — Gastonia, North Carolina, United States
• Clinical Research Inst. of Southern Oregon, Pc — Medford, Oregon, United States
• Piedmont Research Partners LLC — Old Point Station, South Carolina, United States
• S. Carolina Pharmaceutical Research — Spartanburg, South Carolina, United States
• Baylor College of Medicine; Ben Taub Hospital- Guntupalli — Houston, Texas, United States
• Centex Studies — Houston, Texas, United States
• Western Washington Medical Group — Everett, Washington, United States
• Premier Clinical Research — Spokane, Washington, United States
• MultiCare Health Center of Washington — Tacoma, Washington, United States
• Centro Médico Dra de Salvo — Buenos Aires, Argentina
• Instituto Ave Pulmo — Mar del Plata, Argentina
• Centro Respiratorio Quilmes — Quilmes, Argentina
• Investigaciones en Patologias Respiratorias — San Miguel de Tucumán, Argentina
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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