NCT05878769

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: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Astegolimab	Participants will receive SC astegolimab Q2W

Timeline

• Start date: 2023-06-28
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-05-26
• Last updated: 2026-04-02

Locations

483 sites across 40 countries: United States, 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

Regulatory

• FDA-regulated drug study