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

Roche

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02546700

2015-001122-42 (EudraCT Number)

WB29804

Details and patient eligibility

About

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.

Enrollment: 309 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 4 patient groups, including a placebo group

Lebrikizumab: Biomarker-high

Experimental group

Description:

Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.

Treatment:

Drug: Lebrikizumab

Lebrikizumab: Biomarker-low

Experimental group

Description:

Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.

Treatment:

Drug: Lebrikizumab

Placebo: Biomarker-high

Placebo Comparator group

Description:

Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.

Treatment:

Drug: Placebo

Placebo: Biomarker-low

Placebo Comparator group

Description:

Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.

Treatment:

Drug: Placebo