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A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507093-40-00
Acronym
GB43311
Enrollment
613
Registered
2024-04-02
Start date
2022-01-27
Completion date
2025-02-07
Last updated
2025-06-18

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

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

Detailed description

1.Time to first moderate or severe COPD exacerbation during the 52-week treatment period, 2. Absolute change from baseline in HRQoL at Week 52, as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score, 3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52, 4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52, 5. Absolute change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52, 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period, 7. Absolute change from baseline in five-repetition sit-to-stand test (5STS) time (seconds) at Week 52, 8. Incidence and severity of adverse events, 9. Serum concentration of astegolimab at specified timepoints, 10. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Interventions

None listed

Sponsors

Genentech Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
1.Time to first moderate or severe COPD exacerbation during the 52-week treatment period, 2. Absolute change from baseline in HRQoL at Week 52, as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score, 3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52, 4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52, 5. Absolute change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52, 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period, 7. Absolute change from baseline in five-repetition sit-to-stand test (5STS) time (seconds) at Week 52, 8. Incidence and severity of adverse events, 9. Serum concentration of astegolimab at specified timepoints, 10. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

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