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

Last updated: May 5, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

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: 124
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

    Active - Recruiting

  • Gold Coast University Hospital

    Southport, 4215
    Australia

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hôpital de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • Maritime Neurology

    Halifax, B3R 1V9
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, K1Y 4E9
    Canada

    Active - Recruiting

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

    Chengdu, 610072
    China

    Active - Recruiting

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, 510120
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Active - Recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

  • Cyprus Institute of Neurology and Genetics

    Egkomi, 2371
    Cyprus

    Active - Recruiting

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

    Pardubice, 532 03
    Czech Republic

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet

    København, 2100
    Denmark

    Active - Recruiting

  • Turun Yliopistollinen Keskussairaala

    Turku, 20521
    Finland

    Active - Recruiting

  • LLC Caucasus Medical Centre

    Tbilisi, 186
    Georgia

    Active - Recruiting

  • New Hospitals

    Tbilisi, 114
    Georgia

    Active - Recruiting

  • Petre Sarajishvili Institute of Neurology

    Tbilisi, 112
    Georgia

    Active - Recruiting

  • Pineo Medical Ecosystem

    Tbilisi, 114
    Georgia

    Active - Recruiting

  • Chiba University Hospital

    Chuo-Ku, 260-8677
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • General Hanamaki Hospital

    Hanamaki-shi, 025-0075
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551
    Japan

    Active - Recruiting

  • National Hospital Organization Utano National Hospital

    Kyoto-Shi, 616-8255
    Japan

    Active - Recruiting

  • IUHW Narita Hospital

    Narita, 286-8520
    Japan

    Active - Recruiting

  • National Hospital Organization Hokkaido Medical Center

    Sapporo-Shi, 063-0005
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-Ku, 160-0023
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita-Shi, 565-0871
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok hospital

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 2841
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 3722
    Korea, Republic of

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065
    Poland

    Active - Recruiting

  • Centrum Medyczne Neurologia Slaska

    Katowice, 40-689
    Poland

    Active - Recruiting

  • Krakowska Akademia Neurologii

    Kraków, 31-505
    Poland

    Active - Recruiting

  • SP ZOZ Szpital Uniwersytecki

    Kraków, 31-503
    Poland

    Active - Recruiting

  • CLINIREM Sp z o.o.

    Lublin, 20-064
    Poland

    Active - Recruiting

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis

    Nis, 18 000
    Serbia

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 8003
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28304
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Göteborg, 413 45
    Sweden

    Active - Recruiting

  • Neurology Offices of South Florida

    Boca Raton, Florida 33428-4221
    United States

    Active - Recruiting

  • SFM Clinical Research, LLC

    Boca Raton, Florida 33487-2768
    United States

    Active - Recruiting

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33620
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas 78759-8402
    United States

    Active - Recruiting

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