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Активно (без набиране) Фаза 3 NCT04009499

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Psoriatic Arthritis

Спонсор: UCB Biopharma SRL

Налично на: БГ
Обобщение
This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).
Кой може да участва
Inclusion Criteria: * In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study * Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria * Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception Exclusion Criteria: * Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP) * Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator * Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
Места на провеждане 14
Австралия (1)
Pa0012 30005
Camberwell
Белгия (1)
Pa0012 40003
Genk
Канада (1)
Pa0012 50041
Québec
Чехия (1)
Pa0012 40061
Brno
Франция (1)
Pa0012 40068
Chambray-lès-Tours
Германия (1)
Pa0012 40074
Bad Doberan
Унгария (1)
Pa0012 40081
Budapest
Италия (1)
Pa0012 40084
Catania
Япония (1)
Pa0012 20035
Bunkyō City
Полша (1)
Pa0012 40093
Bialystok
Russia (1)
Pa0012 20002
Moscow
Испания (1)
Pa0012 40045
A Coruña
Великобритания (1)
Pa0012 40109
Oxford
САЩ (1)
Pa0012 50017
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.08.2019
Крайна дата
25.05.2026
Регистрационен номер
NCT04009499
Източник
anzctr
Запитване за медицински туризъм

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