Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations (NCT07566195) | Clinical Trial Compass
RecruitingPhase 3
Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations
France59 participantsStarted 2026-05-05
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Clinically important pulmonary disease other than COPD.
. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial focused specifically on long-term safety and tolerability of tozorakimab, what does that mean for what's already known about whether it actually helps reduce my COPD exacerbations, and is that enough information for me to make an informed decision about joining?
2The trial's main thing being measured is adverse events — so is the primary goal here to gather more safety data rather than to show benefit for me personally, and how should I weigh that when thinking about whether this is right for my situation?
3Given that I have a history of COPD exacerbations, would my doctor think my current standard treatments should be optimized first before considering a long-term safety study like this one?
4How long would I need to be on tozorakimab as part of this trial, and given my day-to-day life and how my COPD affects me, is the commitment of a long-term study something my care team thinks is realistic for me?
5Are there other approved treatments or ongoing trials that might be more directly focused on reducing my exacerbations, rather than primarily studying the long-term safety profile of a drug like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.