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

RECRUITINGPhase 3Sponsored by Hoffmann-La Roche
Actively Recruiting
PhasePhase 3
SponsorHoffmann-La Roche
Started2023-06-28
Est. completion2027-06-30
Eligibility
Age40 Years – 90 Years
Healthy vol.Accepted
Locations68 sites

Summary

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.

Eligibility

Age: 40 Years – 90 YearsHealthy volunteers accepted
Inclusion Criteria:

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

Exclusion Criteria:

* 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

Conditions2

COPDChronic Obstructive Pulmonary Disease

Locations68 sites

UAB Lung Health Center
Birmingham, Alabama, 35205-2610
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305
Jasper Summit Research LLC
Jasper, Alabama, 35501
Pulmonary Associates of Mobile PC
Mobile, Alabama, 36608-3135
Pulmonary Associates Deer Valley Office
Phoenix, Arizona, 85027-5163

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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