A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
NCT ID: NCT06558279
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
141 participants
INTERVENTIONAL
2024-09-18
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efgartigimod PH20 SC in part A+B
Participants receiving efgartigimod PH20 SC during part A and part B
Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC in Part A + Efgartigimod PH20 SC in Part B
Participants receiving placebo PH20 SC in Part A and Efgartigimod PH20 SC in Part B
Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC
Subcutaneous placebo PH20 SC given by prefilled syringe
Interventions
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Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC
Subcutaneous placebo PH20 SC given by prefilled syringe
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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HonorHealth Neurology - Bob Bové Neuroscience Institute
Scottsdale, Arizona, United States
Loma Linda University Health
Loma Linda, California, United States
USC Roski Eye Institute - Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Neurology Offices of South Florida
Boca Raton, Florida, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of California Irvine
Columbia, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Neurological Disorders Clinic
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Martha Morehouse Medical plaza
Columbus, Ohio, United States
Penn Medicine University City
Philadelphia, Pennsylvania, United States
National Neuromuscular Research Institute
Austin, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
Box Hill Hospital
Box Hill, , Australia
The Alfred Hospital
Melbourne, , Australia
Gold Coast University Hospital
Southport, , Australia
Universitätsklinikum AKH Wien
Vienna, , Austria
UZ Leuven
Leuven, , Belgium
Hôpital de la Citadelle
Liège, , Belgium
Maritime Neurology
Halifax, , Canada
London Health Sciences Centre
London, , Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, , Canada
Ottawa Hospital Research Institute
Ottawa, , Canada
Hopital de L'enfant Jesus
Québec, , Canada
Toronto General Hospital
Toronto, , Canada
Xiangya Hospital Central South University
Changsha, , China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, , China
The First Affiliated Hospital of Guangzhou University Chinese Medicine
Guangzhou, , China
Qilu Hospital of Shandong University
Jinan, , China
The First Affiliated Hospital of Nanchang University - Xianghu Campus
Nanchang, , China
Huashan Hospital Fudan University
Shanghai, , China
Shijiazhuang People's Hospital - Fangbeilu Campus
Shijiazhuang, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Renmin Hospital of Wuhan University - Main Campus
Wuhan, , China
Cyprus Institute of Neurology and Genetics
Égkomi, , Cyprus
Fakultni nemocnice Brno
Brno, , Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, , Czechia
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Turun Yliopistollinen Keskussairaala
Turku, , Finland
Hôpital Fondation Adolphe de Rothschild
Paris, , France
Petre Sarajishvili Institute of Neurology
Tbilisi, , Georgia
New Hospitals
Tbilisi, , Georgia
Pineo Medical Ecosystem
Tbilisi, , Georgia
LLC Caucasus Medical Centre
Tbilisi, , Georgia
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universität Georg August
Göttingen, , Germany
Eginitio Hospital
Athens, , Greece
University General Hospital of Patras
Pátrai, , Greece
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, , Italy
IRCCS Istituto dell Scienze Neurologiche di Bologna
Bologna, , Italy
Ospedale San Raffaele S.r.l.
Milan, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
AORN Antonio Cardarelli
Napoli, , Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, , Italy
Chiba University Hospital
Chūōku, , Japan
Kyushu University Hospital
Fukuoka, , Japan
General Hanamaki Hospital
Hanamaki-shi, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Saitama Medical Center
Kawagoe, , Japan
National Hospital Organization Utano National Hospital
Kyoto, , Japan
IUHW Narita Hospital
Narita, , Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, , Japan
Kindai University Hospital
Sayama, , Japan
Tokyo Medical University Hospital
Shinjuku-Ku, , Japan
Osaka University Hospital
Suita-Shi, , Japan
Leids Universitair Medisch Centrum
Leiden, , Netherlands
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, , Poland
Centrum Medyczne Neurologia Slaska
Katowice, , Poland
SP ZOZ Szpital Uniwersytecki
Krakow, , Poland
Krakowska Akademia Neurologii
Krakow, , Poland
CLINIREM Sp z o.o.
Lublin, , Poland
ULS de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, , Portugal
ULS de Santo António, EPE - Hospital de Santo António
Porto, , Portugal
University Clinical Center of Serbia
Belgrade, , Serbia
University Clinical Center Nis
Niš, , Serbia
Kyungpook National University Chilgok hospital
Daegu, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario de Donostia
San Sebastián, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Mediclinic Parkview
Dubai, , United Arab Emirates
Royal Sussex County Hospital
Brighton, , United Kingdom
Panthera Biopartners - Glasgow
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Dementech Neurosciences Clinical Academic Centre
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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2024-514133-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2315
Identifier Type: -
Identifier Source: org_study_id
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