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