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



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:9/7/2017
Start Date:September 30, 2015
End Date:November 25, 2016

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A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a History of Exacerbations

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.


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
We found this trial at
22
sites
Jamaica, New York 11435
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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Birmingham, AL
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
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Berlin, NJ
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Buenos Aires,
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Columbus, Georgia 31904
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Columbus, GA
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Everett, Washington 98208
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Everett, WA
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442 East Long Avenue
Gastonia, North Carolina 28054
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Gastonia, NC
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Houston, Texas 77062
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Houston, TX
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Houston, TX
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Indian Land, South Carolina 29707
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Indian Land, SC
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Lake Charles, Louisiana 70601
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Lake Charles, LA
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Medford, OR
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Miami, Florida 33126
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Miami, FL
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Northridge, California 91324
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Northridge, CA
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Palm Springs, California 92262
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Palm Springs, CA
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Peoria, AZ
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Port Orange, Florida 32127
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Port Orange, FL
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Saint Louis, Missouri 63141
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Saint Louis, MO
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Savannah, Georgia 31405
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Savannah, GA
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Spokane, Washington 99204
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Spokane, WA
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Tacoma, Washington 98405
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Tacoma, WA
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