Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAstraZeneca
About this trial
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 criteria
Qualifiers
Participants previously randomized in predecessor studies.
Participants should be affiliated with the French Social Security system.
Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies.
Capable of giving signed informed consent.
Disqualifiers
Clinically important pulmonary disease other than COPD.
Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
Current alcohol, drug or chemical abuse.
Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.
Trial design
Treatments tested in this trial
- Tozorakimab Dose Regimen 1
- Tozorakimab Dose Regimen 2
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
AstraZeneca
Lead sponsor
Clinact, Multihealth Group
Collaborator
Contract Research Organization
Collaborator
Source ClinicalTrials.gov