A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Recruiting now · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

Key facts

Study ID

NCT05878769

Run by

Hoffmann-La Roche

People needed

2000

Starts

2023-06-28

Expected to finish

2034-07-01

Last updated by the study team

2026-08-05

Who can join

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

You may qualify if…

• Completion of the 52-week treatment period in either parent GB43311 or GB44332

You may not qualify if…

• Withdrawal of consent and/or premature discontinuation from parent study
• Any permanent discontinuation of study drug in parent study
• Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
• Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
• Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
• Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Where it is running

• UAB Lung Health Center — Birmingham, Alabama, United States (enrolling)
• Jasper Summit Research LLC — Jasper, Alabama, United States (enrolling)
• SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS — Dothan, Alabama, United States (enrolling)
• Pulmonary Associates Deer Valley Office — Phoenix, Arizona, United States (enrolling)
• AES - DRS - Synexus Clinical Research US, Inc. - Tucson — Tucson, Arizona, United States (enrolling)
• Kern Allergy and Medical Research — Bakersfield, California, United States (enrolling)
• Cadena Care Institute, LLC — Poway, California, United States (enrolling)
• Pulmonary Associates of Mobile PC — Mobile, Alabama, United States (enrolling)
• St Francis Medical Institute ClinEdge PPDS — Clearwater, Florida, United States (enrolling)
• Finlay Medical Research Corporation — Greenacres City, Florida, United States (enrolling)
• Flourish Research - Leesburg - PPDS — Leesburg, Florida, United States (enrolling)
• Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States (enrolling)
• San Marcus Research Clinic Inc. — Miami, Florida, United States (enrolling)
• Finlay Medical Research Corporation — Miami, Florida, United States (enrolling)
• Oceane7 Medical & Research Center, Inc. — Miami, Florida, United States (enrolling)
• Research Institute of South Florida Inc — Miami, Florida, United States (enrolling)
• Diverse Clinical Research, LLC — Miami, Florida, United States (enrolling)
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States (enrolling)
• Florida Institute for Clinical Research, LLC — Orlando, Florida, United States (enrolling)
• Flourish Research - Orlando - PPDS — Winter Park, Florida, United States (enrolling)
• Pivotal Research Solutions — Stonecrest, Georgia, United States (enrolling)
• Northwestern Center for Clinical Research — Chicago, Illinois, United States (enrolling)
• ASHA Clinical Research - ClinEdge - PPDS — Hammond, Indiana, United States (enrolling)
• Best Clinical Trials — New Orleans, Louisiana, United States (enrolling)
• Paul A. Shapero, MD, PA — Bangor, Maine, United States (enrolling)

Full record on ClinicalTrials.gov

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