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

Last updated: July 1, 2026
Sponsor: argenx
Overall Status: Active - Not Recruiting

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Sarcopenia

Neuropathy

Treatment

Efgartigimod PH20 SC

Placebo PH20 SC

Clinical Study ID

NCT06558279
ARGX-113-2315
2024-514133-38-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 forAChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormalneurophysiology testing and history on positive edrophonium chloride testing ordemonstrated 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 2ocular items with a score of at least 2

Exclusion

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 studythat would interfere with an accurate assessment of clinical symptoms of ocularmyasthenia gravis or puts the participant at undue risk

Study Design

Total Participants: 141
Treatment Group(s): 2
Primary Treatment: Efgartigimod PH20 SC
Phase: 3
Study Start date:
September 18, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Box Hill Hospital

    Box Hill, 3128
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Site Not Available

  • Gold Coast University Hospital

    Southport, 4215
    Australia

    Site Not Available

  • Universitätsklinikum AKH Wien

    Vienna, 1090
    Austria

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Hôpital de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Maritime Neurology

    Halifax, B3R 1V9
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, N6A 5A5
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, H2X 0A9
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute

    Ottawa, K1Y 4E9
    Canada

    Site Not Available

  • Hopital de L'enfant Jesus

    Québec, G1J 1Z4
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, M5G 2C4
    Canada

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, 410008
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Site Not Available

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, 510120
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou University Chinese Medicine

    Guangzhou, 510405
    China

    Site Not Available

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou 1809858, 510120
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University - Xianghu Campus

    Nanchang, 330000
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Site Not Available

  • Shijiazhuang People's Hospital - Fangbeilu Campus

    Shijiazhuang, 050011
    China

    Site Not Available

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan, 430060
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030
    China

    Site Not Available

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan 1791247, 430060
    China

    Site Not Available

  • Cyprus Institute of Neurology and Genetics

    Égkomi, 2371
    Cyprus

    Site Not Available

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

    Pardubice, 532 03
    Czech Republic

    Active - Recruiting

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Turun Yliopistollinen Keskussairaala

    Turku, 20521
    Finland

    Site Not Available

  • Hôpital Fondation Adolphe de Rothschild

    Paris, 75019
    France

    Site Not Available

  • LLC Caucasus Medical Centre

    Tbilisi, 186
    Georgia

    Site Not Available

  • New Hospitals

    Tbilisi, 114
    Georgia

    Site Not Available

  • Petre Sarajishvili Institute of Neurology

    Tbilisi, 112
    Georgia

    Site Not Available

  • Pineo Medical Ecosystem

    Tbilisi, 114
    Georgia

    Site Not Available

  • LLC Caucasus Medical Centre

    Tbilisi 611717, 186
    Georgia

    Site Not Available

  • New Hospitals

    Tbilisi 611717, 114
    Georgia

    Site Not Available

  • Petre Sarajishvili Institute of Neurology

    Tbilisi 611717, 112
    Georgia

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Universität Georg August

    Göttingen, 37075
    Germany

    Site Not Available

  • Eginitio Hospital

    Athens, 115 28
    Greece

    Site Not Available

  • University General Hospital of Patras

    Pátrai, 265 04
    Greece

    Site Not Available

  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • IRCCS Istituto dell Scienze Neurologiche di Bologna

    Bologna, 40139
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133
    Italy

    Site Not Available

  • Ospedale San Raffaele S.r.l.

    Milan, 20132
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan 6951411, 20133
    Italy

    Site Not Available

  • AORN Antonio Cardarelli

    Naples, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, 00189
    Italy

    Site Not Available

  • Chiba University Hospital

    Chūōku, 260-8677
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • General Hanamaki Hospital

    Hanamaki-shi, 025-0075
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima, 734-8551
    Japan

    Site Not Available

  • Saitama Medical Center

    Kawagoe, 350-0844
    Japan

    Site Not Available

  • National Hospital Organization Utano National Hospital

    Kyoto, 616-8255
    Japan

    Site Not Available

  • IUHW Narita Hospital

    Narita, 286-8520
    Japan

    Site Not Available

  • IUHW Narita Hospital

    Narita 2111684, 286-8520
    Japan

    Active - Recruiting

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, 063-0005
    Japan

    Site Not Available

  • Kindai University Hospital

    Sayama, 589-8511
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-Ku, 160-0023
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita-Shi, 565-0871
    Japan

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 2841
    Korea, Republic of

    Active - Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Centrum Medyczne Neurologia Slaska

    Katowice, 40-689
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii

    Krakow, 31-505
    Poland

    Site Not Available

  • SP ZOZ Szpital Uniwersytecki

    Krakow, 31-503
    Poland

    Site Not Available

  • SP ZOZ Szpital Uniwersytecki

    Krakow 3094802, 31-503
    Poland

    Site Not Available

  • Krakowska Akademia Neurologii

    Kraków, 31-505
    Poland

    Active - Recruiting

  • CLINIREM Sp z o.o.

    Lublin, 20-064
    Poland

    Site Not Available

  • ULS de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035
    Portugal

    Site Not Available

  • ULS de Santo António, EPE - Hospital de Santo António

    Porto, 4099-001
    Portugal

    Site Not Available

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Clinical Center Nis

    Niš, 18 000
    Serbia

    Site Not Available

  • Kyungpook National University Chilgok hospital

    Daegu, 41404
    South Korea

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 2841
    South Korea

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 3722
    South Korea

    Site Not Available

  • Korea University Anam Hospital

    Seoul 1835848, 2841
    South Korea

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 8003
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona 3128760, 8003
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28304
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    San Sebastián, 20014
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45
    Sweden

    Site Not Available

  • Mediclinic Parkview

    Dubai, 51122
    United Arab Emirates

    Site Not Available

  • Royal Sussex County Hospital

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • Panthera Biopartners - Glasgow

    Glasgow, G51 4TY
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Dementech Neurosciences Clinical Academic Centre

    London, W1G 9ST
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • HonorHealth Neurology - Bob Bové Neuroscience Institute

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Loma Linda University Health

    Loma Linda, California 92354
    United States

    Site Not Available

  • USC Roski Eye Institute - Los Angeles

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Neurology Offices of South Florida

    Boca Raton, Florida 33428-4221
    United States

    Site Not Available

  • SFM Clinical Research, LLC

    Boca Raton, Florida 33487-2768
    United States

    Site Not Available

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33620
    United States

    Site Not Available

  • Neurology Offices of South Florida

    Boca Raton 4148411, Florida 4155751 33428-4221
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of California Irvine

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke Neurological Disorders Clinic

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Martha Morehouse Medical plaza

    Columbus, Ohio 43221
    United States

    Site Not Available

  • Penn Medicine University City

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • National Neuromuscular Research Institute

    Austin, Texas 78759-8402
    United States

    Site Not Available

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Site Not Available

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