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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05878769

Enrollment

2000

Registered

2023-05-26

Start date

2023-06-28

Completion date

2027-06-30

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease, COPD

Brief 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.

Interventions

DRUGAstegolimab

Participants will receive SC astegolimab Q2W

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

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

Design outcomes

Primary

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

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026