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

Ki vehet részt

• 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

Ki nem vehet részt

• 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