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RECRUITING
NCT07566195
PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2026-05-05

Completion Date

2028-12-29

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

Tozorakimab Dose Regimen 1

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

DRUG

Tozorakimab 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