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A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Astegolimab, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Documented COPD diagnosis for ≥ 12 months
* History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
* Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening
* Post-bronchodilator FEV1/FVC \< 0.70 at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
* Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
* On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
* Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Exclusion Criteria

* Current documented diagnosis of asthma
* History of clinically significant pulmonary disease other than COPD
* Diagnosis of 1-antitrypsin deficiency
* History of long-term treatment with oxygen at \> 4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
* History of lung transplant
* Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
* Upper or lower respiratory tract infection within 4 weeks prior to or during screening
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Locations (382)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Bakersfield, California, United States
Walnut Creek, California, United States
Greenacres City, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
The Villages, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Stonecrest, Georgia, United States
Hammond, Indiana, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Farmington Hills, Michigan, United States
Flint, Michigan, United States
Lathrup Village, Michigan, United States
Troy, Michigan, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Marlton, New Jersey, United States
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