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Набира участници Фаза 3 NCT05271409

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Фаза 3 – широко изпитване преди одобрение
Заболявания: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
Кой може да участва
Inclusion criteria * Participants who are aged \>=12 years at the time of signing Informed Consent Form * Confirmed diagnosis of MOGAD with a history of \>=1 MOGAD relapse in the 12 months prior to screening or \>=2 attacks in the 24 months prior to screening * Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening * High-contrast visual acuity (HCVA) better than 20/800 in each eye at screening * Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening * For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab Exclusion criteria * Presence of aquaporin-4-antibodies immunoglobin G (AQP4-IgG) in the serum * History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis * Any concomitant disease other than MOGAD that may require treatment with ISTs or oral corticosteroids (OCS) or intravenous (IV) corticosteroids at doses \> 20 milligrams (mg) prednisone equivalent per day for \>21 days during the study * Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab * Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline * Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection) * Participants with positive screening tests for hepatitis B and C * Receipt of live or live attenuated vaccine within 6 weeks prior to baseline * History of severe allergic reaction to a biologic agent
Места на провеждане 11
Австралия (1)
Brain and Mind Research Institute
Camperdown , New South Wales
Бразилия (1)
Instituto de Neurologia de Curitiba
Curitiba , Paraná
Канада (1)
London Health Sciences Centre Uni Campus
London , Ontario
Франция (1)
Hopital Pierre Wertheimer
Bron
Германия (1)
NeuroCure Clinical Research Center (NCRC)
Berlin
ACTIVE_NOT_RECRUITING
Израел (1)
Hadassah University Hospital Ein Kerem
Jerusalem
Италия (1)
Ospedale Pediatrico Bambino Gesù
Rome , Lazio
WITHDRAWN
Япония (1)
Chiba University Hospital
Chiba
Полша (1)
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice
ACTIVE_NOT_RECRUITING
Южна Корея (1)
National Cancer Center
Goyang-si
ACTIVE_NOT_RECRUITING
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
30.08.2022
Крайна дата
31.12.2028
Регистрационен номер
NCT05271409
Източник
anzctr
Запитване за медицински туризъм

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