Long-term safety of tozorakimab in people with COPD who have had flare-ups
Tests tozorakimab's long-term safety in adults with COPD and past flare-ups.
Plain-language title generated from the registry record
Registry title: Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations
Key facts
- Where
- Aix En Provence, Brest, Colmar Cedex, Epagny Metz-tessy, Grenoble Cedex 9, Lyon, Marseille, Montpellier Cedex 05, Pessac, Quimper Cedex, Saint-Herblain, Toulouse, and Villefranche Sur Saone Cedex, FranceSee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07566195, who can take part
Where in France
- Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-PertuisAix En Provence, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Centre Hospitalier De ColmarColmar Cedex, FranceTaking people
- Centre Hospitalier Annecy GenevoisEpagny Metz-tessy, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Hôpital de la Croix RousseLyon, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- CHU de MontpellierMontpellier Cedex 05, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Centre Hospitalier Intercommunal De CornouailleQuimper Cedex, FranceTaking people
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Les Hopitaux Nord-OuestVillefranche Sur Saone Cedex, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07566195EU 2025-523690-41-00
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Current alcohol, drug or chemical abuse; Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO; Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO; Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO; Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication; Chronic use of antibiotics if the duration of treatment is < 3 months prior to Visit 1 of ROMEO (first IMP administration). Chronic macrolide or other antibiotic therapy is allowed provided the participant has been on a stable dose/regimen for ≥ 3 months prior to Visit 1 of ROMEO (first IMP administration) and has had at least one COPD exacerbation while on stable therapy; Use of allergen immunotherapy within 3 months of Visit 1 of ROMEO (first IMP administration), except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1; Participation in any interventional clinical trial or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer; Clinically important pulmonary disease other than COPD; Known history of:; Severe allergic reaction to any monoclonal and polyclonal antibody; Allergy or reaction to any component of the IMP formulation; Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor; Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration); Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site); Participants who are not able to comply with the study requirements, procedures, and restrictions.