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

Recruiting now · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease, COPD

In brief

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.

Key facts

Study ID

NCT07566195

Run by

AstraZeneca

People needed

59

Starts

2026-05-05

Expected to finish

2028-12-29

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration).
• 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.
• 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.

Where it is running

• Research Site — Toulouse, France (enrolling)
• Research Site — Brest, France (enrolling)
• Research Site — Aix-en-Provence, France (enrolling)
• Research Site — Gleizé, France (enrolling)
• Research Site — Grenoble, France (enrolling)
• Research Site — Lyon, France (enrolling)
• Research Site — Marseille, France (enrolling)
• Research Site — Montpellier, France (enrolling)
• Research Site — Pessac, France (enrolling)
• Research Site — Pringy, France (enrolling)
• Research Site — Quimper, France (enrolling)
• Research Site — Saint-Herblain, France (enrolling)
• Research Site — Colmar, France

Full record on ClinicalTrials.gov

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