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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
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
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)
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