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A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations (PROSPERO)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501063-41-00
Acronym
D9180C00008
Enrollment
802
Registered
2023-03-27
Start date
2023-04-20
Completion date
Unknown
Last updated
2026-01-19

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 severe COPD exacerbation for Tozorakimab versus placebo in former smokers.

Detailed description

Annualised rate of severe COPD exacerbations in former or current smokers., Time to first severe COPD exacerbations in former smokers., Time to first severe COPD exacerbations in former or current smokers., Time to First Moderate to Severe COPD Exacerbation., Annualised Rate of Moderate-to-Severe COPD Exacerbations., Time to Death (All-cause mortality)., Pharmacokinetics, Immunogenicity, To assess the long-term safety and tolerability of tozorakimab, Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits in former smokers., Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits in former or current smokers.

Interventions

DRUG-
DRUGTozorakimab - Placebo

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Annualized rate of severe COPD exacerbation for Tozorakimab versus placebo in former smokers.

Secondary

MeasureTime frame
Annualised rate of severe COPD exacerbations in former or current smokers., Time to first severe COPD exacerbations in former smokers., Time to first severe COPD exacerbations in former or current smokers., Time to First Moderate to Severe COPD Exacerbation., Annualised Rate of Moderate-to-Severe COPD Exacerbations., Time to Death (All-cause mortality)., Pharmacokinetics, Immunogenicity, To assess the long-term safety and tolerability of tozorakimab, Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits in former smokers., Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits in former or current smokers.

Countries

Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

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