NCT06040086

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,454 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study.
DRUG	Tozorakimab	Administered subcutaneously tozorakimab and placebo throughout the study.

Timeline

• Start date: 2023-09-22
• Primary completion: 2026-03-06
• Completion: 2026-05-22
• First posted: 2023-09-15
• Last updated: 2026-03-18

Locations

368 sites across 29 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study