CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 2,000 target
Drug / intervention
Astegolimabdrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Completion of 52-week treatment period in parent study GB43311 or GB44332
Key exclusion· 6
  • ✕Withdrawal of consent and/or premature discontinuation from parent study
  • ✕Any permanent discontinuation of study drug in parent study
  • ✕Significant non-compliance in parent study, specifically missing scheduled visits per investigator judgment
  • ✕New diagnosis of asthma per GINA or other accepted guidelines since parent study enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05878769
NCT05878769Phase 3RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted May 26, 2023·Updated Jun 3, 2026

In Brief

A Phase 3 clinical trial evaluating Astegolimab for Chronic Obstructive Pulmonary Disease. Currently recruiting, targeting 2,000 participants across 486 sites in 40 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, 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
Collaborators--

Timeline

Phase 3Recruiting
20242025202620272028202920302031203220332034
First PostedMay 26, 2023
Enrollment StartJun 28, 2023
Primary CompletionJul 1, 2034
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 3.1 years agoPrimary completion in 8.0 years

Arms & Interventions

Open-Label Extensionexperimental

Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Drug: Astegolimab

Interventions

Astegolimabdrug

Participants will receive SC astegolimab Q2W