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

NCT05742802

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Tozorakimab 1, Tozorakimab 2, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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

Exclusion Criteria:

1. 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.
2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
4. Known history of:

1. Severe allergic reaction to any monoclonal and polyclonal antibody.
2. Allergy or reaction to any component of the IP formulation.
5. 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.
6. 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).
7. Participants who are not able to comply with the study requirements, procedures, and restrictions.

Locations (335)

Sheffield, Alabama, United States
Tempe, Arizona, United States
Lincoln, California, United States
Newport Beach, California, United States
Northridge, California, United States
Boynton Beach, Florida, United States
Cape Coral, Florida, United States
Ormond Beach, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Evergreen Park, Illinois, United States
Normal, Illinois, United States
Greenwood, Indiana, United States
Kansas City, Kansas, United States
Bowling Green, Kentucky, United States
Baton Rouge, Louisiana, United States
Zachary, Louisiana, United States
Baltimore, Maryland, United States
White Marsh, Maryland, United States
North Dartmouth, Massachusetts, United States
Farmington Hills, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Buffalo, New York, United States
Durham, North Carolina, United States
Gastonia, North Carolina, United States
Fargo, North Dakota, United States
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