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Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
1596 patients around the world
Available in Argentina, United States, Colombia, Brazil, Peru, Spain
Participants who have completed the study treatment period and have not been prematurely
discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be
offered the opportunity to consent for this Multicentre, Double-blind, Randomised,
Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and
safety of Tozorakimab versus placebo in adult (40 years and older) participants with
symptomatic COPD and with a history of exacerbations
AstraZeneca
1596Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- 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who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.Participants who are willing to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.
- 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.Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.Known history of: Severe allergic reaction to any monoclonal and polyclonal antibody.Known history of: Allergy or reaction to any component of the IP formulation.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.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.
StudyPROSPERO
SponsorAstraZeneca
Study typeInterventional
Conditions
Copd
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05742802
