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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID

NCT05595642

Run by

Hoffmann-La Roche

People needed

1290

Starts

2022-12-29

Expected to finish

2027-09-24

Last updated by the study team

2026-05-20

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS — Dothan, Alabama, United States
• Pulmonary Associates PA — Glendale, Arizona, United States
• AES - DRS - Synexus Clinical Research US, Inc. - Tucson — Tucson, Arizona, United States
• Kern Research — Bakersfield, California, United States
• Allergy & Asthma Medical Group of the Bay Area — Walnut Creek, California, United States
• Finlay Medical Research Corporation — Greenacres City, Florida, United States
• San Marcus Research Clinic Inc. — Miami, Florida, United States
• Oceane7 Medical & Research Center, Inc. — Miami, Florida, United States
• Avantis Clinical Research, LLC — Miami, Florida, United States
• Research Institute of South Florida Inc — Miami, Florida, United States
• Diverse Clinical Research, LLC — Miami, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• AES - DRS - Synexus Clinical Research US, Inc. - The Villages — The Villages, Florida, United States
• AES - DRS - Synexus Clinical Research US, Inc. - Atlanta — Atlanta, Georgia, United States
• Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD — Columbus, Georgia, United States
• Pivotal Research Solutions — Stonecrest, Georgia, United States
• ASHA Clinical Research - ClinEdge - PPDS — Hammond, Indiana, United States
• The Research Group of Lexington, LLC — Lexington, Kentucky, United States
• Best Clinical Trials — New Orleans, Louisiana, United States
• Paul A. Shapero, MD, PA — Bangor, Maine, United States
• Pulmonary Research Institute of Southeast Michigan — Farmington Hills, Michigan, United States
• Flushing Road Internal Medicine and Pediatrics - F — Flint, Michigan, United States
• Revive Research Institute — Lathrup Village, Michigan, United States
• Oita Medical Center — Ōita, Japan

Full record on ClinicalTrials.gov

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