Not Yet RecruitingPhase 3

Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations

France82 participantsStarted 2026-04-30

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 range40 Years

SexALL

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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.
✕. Current alcohol, drug or chemical abuse.
✕. Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.
✕. Known history of:
✕. Severe allergic reaction to any monoclonal and polyclonal antibody.
✕. Allergy or reaction to any component of the IMP formulation.
✕. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.

What they're measuring

Adverse events

Timeframe: 2-3 years

Trial details

NCT IDNCT07566195

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-29

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials