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

RECRUITINGPHASE3

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

A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

NCT05878769•Hoffmann-La Roche

View on ClinicalTrials.gov

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 - 90 years

Sex

ALL

Healthy Volunteers

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

Locations (482)

UAB Lung Health Center

Birmingham, Alabama, United States

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

Dothan, Alabama, United States

Jasper Summit Research LLC

Jasper, Alabama, United States

Pulmonary Associates of Mobile PC

Mobile, Alabama, United States

Pulmonary Associates Deer Valley Office

Phoenix, Arizona, United States

AES - DRS - Synexus Clinical Research US, Inc. - Tucson

Tucson, Arizona, United States

Kern Allergy and Medical Research

Bakersfield, California, United States

Cadena Care Institute, LLC

Poway, California, United States

Apex Clinical Research

San Diego, California, United States

St Francis Medical Institute ClinEdge PPDS

Clearwater, Florida, United States

Key Dates

Start Date

June 28, 2023

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

March 3, 2026

Enrollment

2,000

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Astegolimab

DRUG

Contacts

Reference Study ID Number: GB43374 https://forpatients.roche.com/

CONTACT

888-662-6728 global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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