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Active (not recruiting) Phase 3 NCT06558279

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

Phase 3 – large-scale trial before approval
Conditions: Myasthenia Gravis, Ocular

Sponsor: argenx

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 22
Australia (1)
Box Hill Hospital
Box Hill
Belgium (1)
UZ Leuven
Leuven
Canada (1)
Maritime Neurology
Halifax
China (1)
Xiangya Hospital Central South University
Changsha
Cyprus (1)
Cyprus Institute of Neurology and Genetics
Égkomi
Czech Republic (1)
Fakultni nemocnice Brno
Brno
Denmark (1)
Aarhus Universitetshospital
Aarhus N
Finland (1)
Turun Yliopistollinen Keskussairaala
Turku
France (1)
Hôpital Fondation Adolphe de Rothschild
Paris
Georgia (1)
Petre Sarajishvili Institute of Neurology
Tbilisi
Greece (1)
Eginitio Hospital
Athens
Italy (1)
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo
Japan (1)
Chiba University Hospital
Chūōku
Netherlands (1)
Leids Universitair Medisch Centrum
Leiden
Poland (1)
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
Serbia (1)
University Clinical Center of Serbia
Belgrade
South Korea (1)
Kyungpook National University Chilgok hospital
Daegu
Spain (1)
Hospital Universitario Vall d'Hebron
Barcelona
Sweden (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
United Arab Emirates (1)
Mediclinic Parkview
Dubai
United Kingdom (1)
Royal Sussex County Hospital
Brighton
United States (1)
HonorHealth Neurology - Bob Bové Neuroscience Institute
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.09.2024
Completion date
01.12.2027
Registry ID
NCT06558279
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.