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Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations
Sponsor: AstraZeneca
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
Tozorakimab Dose Regimen 1
Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
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