A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Key facts

Study ID

NCT05037929

Run by

Genentech, Inc.

People needed

1334

Starts

2021-10-05

Expected to finish

2025-07-07

Last updated by the study team

2026-02-25

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented physician diagnosis of COPD for at least 12 months
• History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
• Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
• Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
• Current or former smoker with a minimum of 10 pack-year history
• History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

You may not qualify if…

• Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
• History of clinically significant pulmonary disease other than COPD
• History of long-term treatment with oxygen at >4.0 liters/minute
• Lung volume reduction surgery or procedure within 12 months prior to screening
• Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
• History of lung transplant
• Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
• Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
• Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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

• Jasper Summit Research LLC — Jasper, Alabama, United States
• Pulmonary Associates of Mobile PC — Mobile, Alabama, United States
• Cadena Care Institute, LLC — Poway, California, United States
• Inst. of Healthcare Assessment, Inc. — San Diego, California, United States
• Allianz Research Institute Inc — Westminster, California, United States
• National Jewish Health — Denver, Colorado, United States
• Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS — Leesburg, Florida, United States
• Florida Institute for Clinical Research, LLC — Orlando, Florida, United States
• Clinical Site Partners - Winter Park - HyperCore - PPDS — Winter Park, Florida, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• Medisphere Medical Research Center, Llc — Evansville, Indiana, United States
• Exordia Medical Research, Inc. — Fall River, Massachusetts, United States
• Northern Pines Health Center PC — Buckley, Michigan, United States
• Revive Research Institute — Lathrup Village, Michigan, United States
• Cardio-Pulmonary Associates — Chesterfield, Missouri, United States
• Blessing Health Hannibal — Hannibal, Missouri, United States
• Midwest Chest Consultants — Saint Charles, Missouri, United States
• CARE Clinical Research — St Louis, Missouri, United States
• Midwest Clinical Research LLC — St Louis, Missouri, United States
• Sierra Clinical Research - ClinEdge - PPDS — Las Vegas, Nevada, United States
• American Health Research Inc. — Charlotte, North Carolina, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• Carolina Research Center — Shelby, North Carolina, United States
• Southeastern Research Center — Winston-Salem, North Carolina, United States
• SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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