Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 3 NCT06558279

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Myasthenia Gravis, Ocular

Спонсор: argenx

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.
Кой може да участва
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies * Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy" * Is MGFA Class I (any ocular muscle weakness) * Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2 Exclusion Criteria: * Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia * Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk
Места на провеждане 22
Австралия (1)
Box Hill Hospital
Box Hill
Белгия (1)
UZ Leuven
Leuven
Канада (1)
Maritime Neurology
Halifax
Китай (1)
Xiangya Hospital Central South University
Changsha
Cyprus (1)
Cyprus Institute of Neurology and Genetics
Égkomi
Чехия (1)
Fakultni nemocnice Brno
Brno
Дания (1)
Aarhus Universitetshospital
Aarhus N
Финландия (1)
Turun Yliopistollinen Keskussairaala
Turku
Франция (1)
Hôpital Fondation Adolphe de Rothschild
Paris
Georgia (1)
Petre Sarajishvili Institute of Neurology
Tbilisi
Гърция (1)
Eginitio Hospital
Athens
Италия (1)
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo
Япония (1)
Chiba University Hospital
Chūōku
Нидерландия (1)
Leids Universitair Medisch Centrum
Leiden
Полша (1)
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
Сърбия (1)
University Clinical Center of Serbia
Belgrade
Южна Корея (1)
Kyungpook National University Chilgok hospital
Daegu
Испания (1)
Hospital Universitario Vall d'Hebron
Barcelona
Швеция (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
United Arab Emirates (1)
Mediclinic Parkview
Dubai
Великобритания (1)
Royal Sussex County Hospital
Brighton
САЩ (1)
HonorHealth Neurology - Bob Bové Neuroscience Institute
Scottsdale , 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
18.09.2024
Крайна дата
01.12.2027
Регистрационен номер
NCT06558279
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.