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Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations - Trial NCT06040086

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.

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NCT06040086
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06040086
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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)

Study Focus

Placebo

Interventional

drug

Sponsor & Location

AstraZeneca

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 3

Sep 22, 2023

Dec 07, 2026

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 โ‰ฅ 2 moderate or โ‰ฅ 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 disease
Chronic obstructive pulmonary disease, unspecified
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease with acute lower respiratory infection

Data Source

ClinicalTrials.gov

NCT06040086

Non-Device Trial