A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
Subjects who completed either 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 safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
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
Inclusion Criteria:
Exclusion Criteria:
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:
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.
CABA, C1425BEN, Argentina
Ciudad de Buenos Aires, C1414AIF, Argentina
Frankstown, 3199, Australia
Macquarie University, 2109, Australia
Chile, 7770484, Chile
Exohi Thessaloniki, 57010, Greece
Nyíregyháza-Sóstóhegy, 4481, Hungary
Asahikawa-shi, 078-8510, Japan
Fujieda-shi, 426-8677, Japan
Iizuka-shi, 820-8505, Japan
Itabashi-ku, 173-8610, Japan
Iwata-shi, 438-8550, Japan
Kawachinagano-shi, 586-8521, Japan
Matsusaka-shi, 515-8544, Japan
Mizunami-shi, 509-6134, Japan
Shinjuku-ku, 162-8655, Japan
Toshima-ku, 170-0003, Japan
Toyonaka-shi, 560-8552, Japan
Lørenskog, 1478, Norway
Yunlin, 640, Taiwan
Bang Kra So, 11000, Thailand
Muang,, 55000, Thailand
Muang, 22000, Thailand
Mueang, 20000, Thailand