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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505543-39-00
Acronym
D9180C00012
Enrollment
480
Registered
2024-02-05
Start date
2024-02-12
Completion date
Unknown
Last updated
2026-01-26

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 to severe COPD exacerbations in participants who are former smokers.

Detailed description

Annualized rate of moderate to severe COPD exacerbations in former or current smokers, Change from baseline in SGRQ total score in former smokers, Change from baseline in SGRQ total score in former or current smokers, Annualized rate of severe COPD exacerbations in former smokers, Annualized rate of severe COPD exacerbations in former or current smokers, Change from baseline in E-RS:COPD total score in former smokers, Change from baseline in E-RS:COPD total score in former or current smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers, Time to first moderate to severe COPD exacerbation, Time to first severe COPD exacerbation, Change from baseline in CAT total score, Proportion of participants achieving MCID in CAT score, Proportion of participants achieving MCID in SGRQ total score, Proportion of participants achieving MCID in E-RS:COPD total score, Annualized rate of healthcare resource utilization, Change from baseline in rescue medication, Trough serum concentrations of tozorakimab, Presence of anti-drug antibodies, Time to death, Safety and tolerability, Change from baseline in post-bronchodilator FEV1 (mL) in former smokers, Change from baseline in post-bronchodilator FEV1 (mL) in former or current smokers, Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room /Emergency Department visits in former smokers, Annualised rate of COPD exacerbations requiring hospitalisations and/or Emergency Room /Emergency Department visits in former or current smokers

Interventions

DRUG-
DRUGSALBUTAMOL

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.

Secondary

MeasureTime frame
Annualized rate of moderate to severe COPD exacerbations in former or current smokers, Change from baseline in SGRQ total score in former smokers, Change from baseline in SGRQ total score in former or current smokers, Annualized rate of severe COPD exacerbations in former smokers, Annualized rate of severe COPD exacerbations in former or current smokers, Change from baseline in E-RS:COPD total score in former smokers, Change from baseline in E-RS:COPD total score in former or current smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers, Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers, Time to first moderate to severe COPD exacerbation, Time to first severe COPD exacerbation, Change from baseline in CAT total score, Proportion of participants achieving MCID in CAT score, Proportion of participants achieving MCID in SGRQ total score, Proportion of participants achieving MCID in E-RS:COPD total

Countries

Belgium, Bulgaria, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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