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 |
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.
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
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Peoria, Arizona 85381
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