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NOT YET 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

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2026-04-30

Completion Date

2028-12-29

Last Updated

2026-05-04

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)

Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix- Pertuis

Aix-en-Provence, France

Centre Hospitalier Regional Et Universitaire De Brest

Brest, France

Centre Hospitalier de Colmar

Colmar, France

Centre Hospitalier Annecy Genevois

Epagny Metz-Tessy, France

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France

Hôpital de la Croix Rousse

Lyon, France

Centre Hospitalier Regional De Marseille

Marseille, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Centre Hospitalier Universitaire de Bordeaux

Pessac, France

Centre Hospitalier Intercommunal De Cornouaille

Quimper, France

Centre Hospitalier Universitaire De Nantes

Saint-Herblain, France

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Les Hopitaux Nord-Ouest

Villefranche-sur-Saône, France