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Active (not recruiting) Phase 3 NCT05742802

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

Phase 3 – large-scale trial before approval
Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
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
Who can participate
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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study. 3.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 35
Argentina (1)
Research Site
Buenos Aires
Australia (1)
Research Site
Campbelltown
Belgium (1)
Research Site
Brussels
Brazil (1)
Research Site
Blumenau
Bulgaria (1)
Research Site
Dupnitsa
Canada (1)
Research Site
Edmonton , Alberta
Chile (1)
Research Site
Chile
China (1)
Research Site
Baotou
Colombia (1)
Research Site
Barranquilla
Czech Republic (1)
Research Site
Brno
Denmark (1)
Research Site
Aalborg
Finland (1)
Research Site
Hämeenlinna
France (1)
Research Site
Bordeaux
Greece (1)
Research Site
Alexandroupoli
Hungary (1)
Research Site
Budapest
India (1)
Research Site
Belagavi
Israel (1)
Research Site
Ashkelon
Italy (1)
Research Site
Bari
Japan (1)
Research Site
Asahikawa-shi
Mexico (1)
Research Site
Benito Juárez
Netherlands (1)
Research Site
Eindhoven
Norway (1)
Research Site
Lørenskog
Peru (1)
Research Site
Lima
Philippines (1)
Research Site
Baguio City
Poland (1)
Research Site
Bialystok
Romania (1)
Research Site
Brasov
South Korea (1)
Research Site
Daegu
Spain (1)
Research Site
Galdakao
Sweden (1)
Research Site
Gothenburg
Taiwan (1)
Research Site
Hsinchu
Thailand (1)
Research Site
Bang Kra So
Turkey (1)
Research Site
Ankara
United Kingdom (1)
Research Site
Bradford
United States (1)
Research Site
Sheffield , Alabama
Vietnam (1)
Research Site
Hanoi
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
06.03.2023
Completion date
28.05.2026
Registry ID
NCT05742802
Source
anzctr
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