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A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502234-70-00
Acronym
GB44332
Enrollment
683
Registered
2023-06-26
Start date
2023-07-14
Completion date
Unknown
Last updated
2025-08-26

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period

Detailed description

Time to first moderate or severe COPD exacerbation during the 52-week treatment period, Absolute change from baseline in HRQoL at Week 52, as assessed through the SGRQ-C total score, Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52, Absolute change from baseline in E-RS:COPD total score at Week 52, Proportion of participants with improvement in HRQoL, defined as a decrease from baseline of >= 4 points in SGRQ-C total score, at Week 52, Annualized rate of severe COPD exacerbations over the 52-week treatment period, Incidence and severity of all treatment-emergent adverse events (TEAE), including Serious Adverse Events (SAEs), adverse events of special interests (AESIs), and TEAEs leading to death or discontinuation, Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results and electrocardiograms (ECGs), Serum concentration of astegolimab at specified timepoints, Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study, Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period

Interventions

DRUGAstegolimab Placebo

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period

Secondary

MeasureTime frame
Time to first moderate or severe COPD exacerbation during the 52-week treatment period, Absolute change from baseline in HRQoL at Week 52, as assessed through the SGRQ-C total score, Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52, Absolute change from baseline in E-RS:COPD total score at Week 52, Proportion of participants with improvement in HRQoL, defined as a decrease from baseline of >= 4 points in SGRQ-C total score, at Week 52, Annualized rate of severe COPD exacerbations over the 52-week treatment period, Incidence and severity of all treatment-emergent adverse events (TEAE), including Serious Adverse Events (SAEs), adverse events of special interests (AESIs), and TEAEs leading to death or discontinuation, Change from baseline in selected vital signs, Change from baseline in selected clinical laboratory test results and electrocardiograms (ECGs), Serum concentration of astegolimab at specified timepoints, Prevalence of anti-drug antibodies (ADAs)

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026