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Evaluating the long-term safety of astegolimab for COPD patients

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

Phase 3 Interventional Hoffmann-La Roche · NCT05878769

This study is testing the long-term safety and effectiveness of a treatment called astegolimab for people with COPD who have already completed a year of related treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2000 (estimated)
Ages40 Years to 90 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsastegolimab
Locations484 sites (Birmingham, Alabama and 483 other locations)
Trial IDNCT05878769 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term safety and explore the efficacy of astegolimab in patients with chronic obstructive pulmonary disease (COPD) who have previously completed a 52-week treatment period in related studies. Participants will receive astegolimab and will be monitored for safety and effectiveness over an extended period. The study is designed to provide insights into the ongoing management of COPD and the potential benefits of this treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals with COPD who have completed the 52-week treatment period in the parent studies GB43311 or GB44332.

Not a fit: Patients who have withdrawn from the parent study or have developed new significant pulmonary or cardiac diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients with COPD, improving their quality of life.

How similar studies have performed: Other studies have shown promise in evaluating treatments for COPD, but the specific approach of astegolimab in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 483 other locations

+434 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Diseasechronic obstructive pulmonary disease, COPD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.