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

Prior treatment

• 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.

Other illness

• 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.

Other

• 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.

• 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.