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Активно (без набиране) Фаза 3 NCT05063162

A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)

Спонсор: UCB Biopharma SRL

Налично на: БГ
Обобщение
The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).
Кой може да участва
Inclusion Criteria: * Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent * Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD * Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization * Participant must be clinically stable at the time of the Screening Visit and during the Screening Period Exclusion Criteria: * Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant * Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP) * Participant has a current or medical history of primary immunodeficiency * Participant tests positive for aquaporin-4 antibodies at Screening * Participant has a serum total IgG level ≤ 5.5g/L
Места на провеждане 19
Австралия (1)
Mog001 30022
Melbourne
Белгия (1)
Mog001 40123
Anderlecht
Бразилия (1)
Mog001 60033
Porto Alegre
Чехия (1)
Mog001 40195
Hradec Králové
Франция (1)
Mog001 40657
Bron
Германия (1)
Mog001 40659
Berlin
Гърция (1)
Mog001 40850
Athens
Италия (1)
Mog001 40146
Pavia
Япония (1)
Mog001 20225
Bunkyō City
Mexico (1)
Mog001 50486
Culiacán
Полша (1)
Mog001 40840
Bydgoszcz
Южна Корея (1)
Mog001 20226
Goyang-si
Испания (1)
Mog001 40267
Barcelona
Швеция (1)
Mog001 40663
Huddinge
Taiwan (1)
Mog001 20080
Taichung
Турция (1)
Mog001 40849
Bursa
Ukraine (1)
Mog001 20319
Kyiv
Великобритания (1)
Mog001 40661
Liverpool
САЩ (1)
Mog001 50297
Scottsdale , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
89 Years
Здрави доброволци
Не
Начална дата
02.02.2022
Крайна дата
01.07.2027
Регистрационен номер
NCT05063162
Източник
anzctr
Запитване за медицински туризъм

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