What is astegolimab studying for chronic obstructive pulmonary disease (COPD)?

Astegolimab is being studied to understand its long-term safety and effects in people with COPD who have already completed a year of treatment in previous studies. The research aims to gather more information on how this treatment works over an extended period. Hoffmann-La Roche is leading this research to help improve future care options.

Who may be eligible for this COPD clinical trial?

Adults aged 40 to 90 who have completed a 52-week treatment in parent studies GB43311 or GB44332 may be eligible. Participants must not have withdrawn consent or stopped treatment early in the parent study and should not have developed new asthma or significant lung or heart diseases since then. Please review eligibility criteria for more details.

Is there any cost to participate in this COPD clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive all study treatments and assessments without charge.

Actively Recruiting

Phase 3

Age: 40Years - 90Years

All Genders

ID05878769

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

Led by Hoffmann-La Roche · Updated on 2026-06-03

2000

Participants Needed

486

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to assess the long-term safety and explore the effects of astegolimab in adults with chronic obstructive pulmonary disease COPD who have completed a 52-week treatment period in earlier studies named GB43311 or GB44332. The study is an open-label extension phase III trial sponsored by Hoffmann-La Roche, focusing on participants aged 40 to 90 years. Participants who qualify from the parent studies will receive astegolimab through subcutaneous injections every two weeks throughout the study duration. This open-label extension allows all participants to receive the active drug without placebo comparison. During the study, researchers will monitor participants for any adverse events up to 12 weeks after the last dose, focusing on the safety of astegolimab. Participants will be regularly assessed to track any side effects and overall health changes related to their COPD condition while on this treatment. The study began in June 2023 and will continue until July 2034, allowing for long-term observation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 90Years

All Genders

Eligibility Criteria

You may qualify if you...

Completed the 52-week treatment period in either parent study GB43311 or GB44332

You will not qualify if you...

Withdrawal of consent or early stopping from the parent study
Permanent discontinuation of study drug in the parent study
Significant non-compliance in the parent study, including missed visits as judged by the investigator
New diagnosis of asthma since starting the parent study
New significant lung diseases other than COPD since starting the parent study, such as pulmonary fibrosis or sarcoidosis
New unstable heart disease, heart attack, or advanced heart failure since starting the parent study

Research Team

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

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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