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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tozorakimab Dose Regimen 1
DrugParticipants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
Tozorakimab Dose Regimen 2
DrugParticipants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen
Treatment groups
59 Participants
are divided into 2 treatment groupsGroup A: Tozorakimab Dose Regimen 1Experimental treatment 1 intervention
Group B: Tozorakimab Dose Regimen 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Assessments related to AEs include: Occurrence/frequency, Relationship to IMP as assessed by Investigator, Intensity, Seriousness, Death, AEs leading to discontinuation of IMP, Other significant AEs. Medically significant abnormal laboratory results will be reported as AEs.
Time frame
2-3 yearsSponsors and contacts
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AstraZeneca
Lead sponsor
Clinact, Multihealth Group
Collaborator
Contract Research Organization
Collaborator
Source ClinicalTrials.gov