Long-term safety and tolerability of tozorakimab in patients with COPD and history of exacerbations - ROMEO

Inclusion Criteria

• Inclusion Criteria:
• 1. Participants previously randomized in predecessor studies.
• 2. Participants should be affiliated with the French Social Security system.
• 3. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies.
• 4. Capable of giving signed informed consent.
• Exclusion Criteria:
• 1. Clinically important pulmonary disease other than COPD.
• 2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
• 3. Current alcohol, drug or chemical abuse.
• 4. Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.
• 5. Known history of:
• (a) Severe allergic reaction to any monoclonal and polyclonal antibody.
• (b) Allergy or reaction to any component of the IMP formulation.
• 6. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.
• 7. Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.
• 8. 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.
• 9. 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.
• 10. 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.
• 11. Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration).
• 12. 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.
• 13. 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).
• 14. Participants who are not able to comply with the study requirements, procedures, and restrictions.