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NCT06040086Recruiting

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

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)
AstraZenecaPhase 3ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Placebo
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Birmingham,Decatur,Sheffield,Peoria,Newport Beach,Denver,Boynton Beach,Ocala,Ormond Beach,Chicago,Bowling Green,Canton,Chesterfield,Hannibal,Las Vegas,Toms River,Bronx,Union,Elizabethton,El Paso,Houst, Argentina,Belgium,Brazil,Canada,China,France,Germany,Greece,Hungary,Ireland,Italy,Japan,Malaysia,Net
Timeline & enrollment
Phase
Phase 3
Start date
Sep 22, 2023
End date
Dec 07, 2026
Enrollment
1240 participants
Primary outcome

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

Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab
 administered subcutaneously (SC) in adult participants with symptomatic COPD with a history
 of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment.
 Participants should be receiving optimised treatment with inhaled maintenance therapy
 (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate)
 throughout at least the last 3 months prior to enrolment.

ICD-10 classifications
Other chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease, unspecifiedOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06040086
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06040086 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on Chronic Obstructive Pulmonary Disease (COPD). Target enrollment is 1240 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.