Suspended

MIRANDATozorakimab for Symptomatic Chronic Obstructive Pulmonary Disease with History of Exacerbations

Study Aim

This study aims to evaluate the effectiveness of Tozorakimab in reducing the annual rate of moderate to severe COPD exacerbations in former smokers who are currently experiencing symptomatic Chronic Obstructive Pulmonary Disease and have a history of exacerbations, while being treated with optimized inhaled therapy.

What is being tested

Placebo

+ Tozorakimab

Drug

Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 40 to 130 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: September 2023

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 22, 2023

Actual date on which the first participant was enrolled.

This study focuses on testing a drug called tozorakimab for adults who have Chronic Obstructive Pulmonary Disease (COPD) and have experienced frequent worsening of symptoms despite current treatments. These individuals have had at least two moderate or one severe flare-ups of their COPD in the past year. The study aims to find out if tozorakimab can effectively manage symptoms and improve the quality of life for these patients. This research is important as it could lead to better treatment options for people with COPD who continue to suffer from exacerbations. Participants in this study receive tozorakimab through injections under the skin, known as subcutaneous administration. The study observes how the drug affects the participants' symptoms and any side effects that may occur. Participants continue their usual inhaled maintenance therapy, such as combinations of inhaled corticosteroids and bronchodilators, ensuring that any benefits seen are due to the new drug. The study does not have results yet, but aims to determine if tozorakimab is a safe and effective addition to current COPD treatments.

Official TitleA 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)

NCT06040086

Principal SponsorAstraZeneca

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1454 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 130 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

7 inclusion criteria required to participate

Participant must be >= 40 years of age and capable of giving signed informed consent

Documented diagnosis of COPD for at least one year prior to enrolment

Post BD FEV1/FVC < 0.70 and post-BD FEV1 > 20% of predicted normal value

Documented history of >= 2 moderate or >= 1 severe COPD exacerbations within 12 months prior to enrolment

Show More Criteria

20 exclusion criteria prevent from participating

Clinically important pulmonary disease other than COPD

Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection

Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18

Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Dosing subcutaneously with equivalent volume to tozorakimab

Group II

Experimental

Dosing subcutaneously tozorakimab

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 368 locations

Suspended

Research Site

Birmingham, United StatesOpen Research Site in Google Maps

Suspended

Research Site

Decatur, United States

Suspended

Research Site

Sheffield, United States

Suspended

Research Site

Phoenix, United States

Suspended368 Study Centers