Long-Term Safety Study of Astegolimab for COPD

This study is looking at the long-term safety of a drug called astegolimab for people with chronic obstructive pulmonary disease (COPD). It also aims to see how well astegolimab works over time. You can join if you are between 40 and 90 years old and have already completed the 52-week treatment period in one of the previous astegolimab studies (GB43311 or GB44332). The main goal is to track any side effects (adverse events) that happen up to 12 weeks after your last dose of astegolimab. The study plans to enroll 2000 participants.

Study design
This is an interventional study, meaning you will receive a specific treatment. It is designed to evaluate the long-term safety and explore the effectiveness of astegolimab in 2000 participants.
What's involved
Participants will receive astegolimab injections under the skin every two weeks. You must have completed a previous 52-week study to be eligible.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 12 weeks after your last dose of astegolimab.

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NCT05878769

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

Active, Not Recruiting
PHASE3Ages 40–90InterventionalTreatment
Hoffmann-La Roche
~2,000 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Astegolimab

At a glance

Recruiting sites
0 of 481 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of all adverse events (AEs)
Measured over Up to 12 weeks after last dose of study treatment
Chronic Obstructive Pulmonary Disease
481 sites across 113 states
Argentina38
Poland32
Germany28
Japan28
China26
Bulgaria23
Israel13
South Africa13
  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Incidence of all adverse events (AEs)Up to 12 weeks after last dose of study treatment