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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID: NCT05742802
Run by: AstraZeneca
People needed: 1713
Starts: 2023-03-06
Expected to finish: 2026-05-27
Last updated by the study team: 2026-06-25

Who can join

Age: 40 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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.

You may not qualify if…

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.
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.

Where it is running

Research Site — Brno, Czechia
Research Site — Jindřichův Hradec, Czechia
Research Site — Liberec, Czechia
Research Site — Olomouc, Czechia
Research Site — Rokycany, Czechia
Research Site — Aalborg, Denmark
Research Site — Copenhagen, Denmark
Research Site — Hvidovre, Denmark
Research Site — Næstved, Denmark
Research Site — Roskilde, Denmark
Research Site — Vejle, Denmark
Research Site — Hämeenlinna, Finland
Research Site — Helsinki, Finland
Research Site — Kuopio, Finland
Research Site — Turku, Finland
Research Site — Bordeaux, France
Research Site — Brest, France
Research Site — La Tronche, France
Research Site — Lyon, France
Research Site — Marseille, France
Research Site — Montpellier, France
Research Site — Nantes, France
Research Site — Toulouse, France
Research Site — Ahrensburg, Germany
Research Site — Rio de Janeiro, Brazil

Full record on ClinicalTrials.gov

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