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Активно (без набиране) Фаза 3 NCT05742802

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Chronic Obstructive Pulmonary Disease (COPD)

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
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.
Описание
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
Кой може да участва
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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study. 3.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.
Места на провеждане 35
Argentina (1)
Research Site
Buenos Aires
Австралия (1)
Research Site
Campbelltown
Белгия (1)
Research Site
Brussels
Бразилия (1)
Research Site
Blumenau
България (1)
Research Site
Dupnitsa
Канада (1)
Research Site
Edmonton , Alberta
Chile (1)
Research Site
Chile
Китай (1)
Research Site
Baotou
Colombia (1)
Research Site
Barranquilla
Чехия (1)
Research Site
Brno
Дания (1)
Research Site
Aalborg
Финландия (1)
Research Site
Hämeenlinna
Франция (1)
Research Site
Bordeaux
Гърция (1)
Research Site
Alexandroupoli
Унгария (1)
Research Site
Budapest
Индия (1)
Research Site
Belagavi
Израел (1)
Research Site
Ashkelon
Италия (1)
Research Site
Bari
Япония (1)
Research Site
Asahikawa-shi
Mexico (1)
Research Site
Benito Juárez
Нидерландия (1)
Research Site
Eindhoven
Норвегия (1)
Research Site
Lørenskog
Peru (1)
Research Site
Lima
Philippines (1)
Research Site
Baguio City
Полша (1)
Research Site
Bialystok
Румъния (1)
Research Site
Brasov
Южна Корея (1)
Research Site
Daegu
Испания (1)
Research Site
Galdakao
Швеция (1)
Research Site
Gothenburg
Taiwan (1)
Research Site
Hsinchu
Тайланд (1)
Research Site
Bang Kra So
Турция (1)
Research Site
Ankara
Великобритания (1)
Research Site
Bradford
САЩ (1)
Research Site
Sheffield , Alabama
Vietnam (1)
Research Site
Hanoi
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Максимална възраст
130 Years
Здрави доброволци
Не
Начална дата
06.03.2023
Крайна дата
28.05.2026
Регистрационен номер
NCT05742802
Източник
anzctr
Запитване за медицински туризъм

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