Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

Korábbi kezelés

• Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
• 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.

Más betegség

• Known history of:
  • Severe allergic reaction to any monoclonal and polyclonal antibody.
  • Allergy or reaction to any component of the IP formulation.

Laborértékek

• Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.

Egyéb

• Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
• 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 who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
• Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
• FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
• Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
• Capable of giving signed informed consent.