RecruitingPhase 3NCT07566195

Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations

A Phase III, Multicentre, Open-Label, Chronic Dosing, Extension Study to Evaluate the Long-term Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (ROMEO)


Sponsor

AstraZeneca

Enrollment

59 participants

Start Date

May 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

ROMEO is a Phase III, multicentre, open-label, chronic-dosing extension study evaluating the long-term safety of two dose regimens of tozorakimab in participants with COPD and a history of exacerbations. Eligible participants must have completed one of the predecessor studies.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Tozorakimab Dose Regimen 1 and a drug called Tozorakimab Dose Regimen 2 for people with copd and chronic obstructive pulmonary disease. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTozorakimab Dose Regimen 1

Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen

DRUGTozorakimab Dose Regimen 2

Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen


Locations(13)

Research Site

Aix-en-Provence, France

Research Site

Brest, France

Research Site

Colmar, France

Research Site

Gleizé, France

Research Site

Grenoble, France

Research Site

Lyon, France

Research Site

Marseille, France

Research Site

Montpellier, France

Research Site

Pessac, France

Research Site

Pringy, France

Research Site

Quimper, France

Research Site

Saint-Herblain, France

Research Site

Toulouse, France

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NCT07566195


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