An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

Last updated: November 4, 2025
Sponsor: argenx
Overall Status: Completed

Phase

3

Condition

Neuropathy

Sarcopenia

Polymyositis (Inflammatory Muscle Disease)

Treatment

Efgartigimod concentrate for solution for infusion 20 mg/mL

Efgartigimod IV

Clinical Study ID

NCT04980495
ARGX-113-2003
2024-510932-36-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).

Participants will receive efgartigimod throughout the study. The participants will be randomized to the continuous regimen arm or to the cyclic regimen arm. The study consists of a part A (regimen comparison period) where participants will continue the treatment based on the treatment regimen arm they were assigned at randomization. Following part A, participants will enter part B (extension period) where all participants will receive efgartigimod in the continuous regimen. The study duration for participants is up to 138 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years of age, at the time of signing the informed consent.

  • Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation andsupported by a physical exam and confirmed seropositivity for anti-acetylcholinereceptor antibodies (AChR-Abs).

  • Meets the clinical criteria as defined by the Myasthenia Gravis Foundation ofAmerica (MGFA) class II, III, or IV

Exclusion

Exclusion Criteria:

  • Any other condition that, in the opinion of the investigator, would interfere withan accurate assessment of the clinical symptoms of gMG and/or put the participant atundue risk

  • A thymectomy within 3 months of screening

  • Use of the following prior or concomitant therapies:

  1. intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) within 14 days of day 1

  2. Rituximab within 6 months of day 1

  3. Eculizumab within 1 month of day 1

  4. Other monoclonal antibodies (eg, adalimumab, tocilizumab, ixekizumab)

Study Design

Total Participants: 69
Treatment Group(s): 2
Primary Treatment: Efgartigimod concentrate for solution for infusion 20 mg/mL
Phase: 3
Study Start date:
December 16, 2021
Estimated Completion Date:
October 06, 2025

Connect with a study center

  • Investigator Site 26 - AT0430002

    Innsbruck, 6020
    Austria

    Site Not Available

  • Investigator Site 26 - AT0430002

    Innsbruck 2775220, 6020
    Austria

    Site Not Available

  • Investigator Site 27 - AT0430001

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • Investigator Site 27 - AT0430001

    Wien, 1090
    Austria

    Site Not Available

  • Investigator Site 28 - BE0320001

    Leuven, 3000
    Belgium

    Site Not Available

  • Investigator Site 28 - BE0320001

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Investigator Site 29 - CA0019003

    London, N6A 5A5
    Canada

    Site Not Available

  • Investigator Site 29 - CA0019003

    London 6058560, N6A 5A5
    Canada

    Site Not Available

  • Investigator site 37 - CA0019002

    Québec, H3A 2B4
    Canada

    Site Not Available

  • Investigator site 37 - CA0019002

    Québec 6325494, H3A 2B4
    Canada

    Site Not Available

  • Investigator Site 23 - FR0330005

    Bordeaux, 33604
    France

    Site Not Available

  • Investigator Site 23 - FR0330005

    Bordeaux 3031582, 33604
    France

    Site Not Available

  • Investigator Site 24 - FR0330004

    Lille, 59000
    France

    Site Not Available

  • Investigator Site 24 - FR0330004

    Lille 2998324, 59000
    France

    Site Not Available

  • Investigator Site 20 - FR0330001

    Marseille, 13385
    France

    Site Not Available

  • Investigator Site 20 - FR0330001

    Marseille 2995469, 13385
    France

    Site Not Available

  • Investigator Site 25 - FR0330003

    Nice, 06001
    France

    Site Not Available

  • Investigator Site 25 - FR0330003

    Nice 2990440, 06001
    France

    Site Not Available

  • Investigator site 38 - FR0330002

    Paris, 75013
    France

    Site Not Available

  • Investigator site 38 - FR0330002

    Paris 2988507, 75013
    France

    Site Not Available

  • Investigator Site 1 - GEO9950001

    Tbilisi, 0114
    Georgia

    Site Not Available

  • Investigator Site 2 - GEO9950002

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Investigator Site 3 - GEO9950003

    Tbilisi, 0114
    Georgia

    Site Not Available

  • Investigator Site 1 - GEO9950001

    Tbilisi 611717, 0114
    Georgia

    Site Not Available

  • Investigator Site 2 - GEO9950002

    Tbilisi 611717, 0112
    Georgia

    Site Not Available

  • Investigator Site 3 - GEO9950003

    Tbilisi 611717, 0114
    Georgia

    Site Not Available

  • Investigator Site 33 - DE0490004

    Berlin, 10117
    Germany

    Site Not Available

  • Investigator Site 33 - DE0490004

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Investigator Site 36 - DE0490002

    Bochum, 44791
    Germany

    Site Not Available

  • Investigator Site 36 - DE0490002

    Bochum 2947416, 44791
    Germany

    Site Not Available

  • Investigator Site 32 - DE0490001

    Essen, 45147
    Germany

    Site Not Available

  • Investigator Site 32 - DE0490001

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Investigator Site 34 - DE0490005

    Hannover, 30625
    Germany

    Site Not Available

  • Investigator Site 34 - DE0490005

    Hanover 2910831, 30625
    Germany

    Site Not Available

  • Investigator Site 31 - IT0390005

    Bologna, 40139
    Italy

    Site Not Available

  • Investigator Site 31 - IT0390005

    Bologna 3181928, 40139
    Italy

    Site Not Available

  • Investigator Site 30 - IT0390004

    Genova, 16132
    Italy

    Site Not Available

  • Investigator Site 30 - IT0390004

    Genova 8969657, 16132
    Italy

    Site Not Available

  • Investigator Site 21 - IT0390002

    Milan, 20133
    Italy

    Site Not Available

  • Investigator Site 21 - IT0390002

    Milan 3173435, 20133
    Italy

    Site Not Available

  • Investigator site 39 - IT0390006

    Pisa, 56126
    Italy

    Site Not Available

  • Investigator site 39 - IT0390006

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • Investigator Site 22 - IT0390001

    Roma, 00168
    Italy

    Site Not Available

  • Investigator Site 22 - IT0390001

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Investigator Site 35 - NL0310001

    Amsterdam, 1105
    Netherlands

    Site Not Available

  • Investigator Site 35 - NL0310001

    Amsterdam 2759794, 1105
    Netherlands

    Site Not Available

  • Investigator Site 5 - PL0480002

    Krakow 3094802, 31-426
    Poland

    Site Not Available

  • Investigator Site 5 - PL0480002

    Kraków, 31-426
    Poland

    Site Not Available

  • Investigator Site 4 - PL0480001

    Lubin, 20-093
    Poland

    Site Not Available

  • Investigator Site 4 - PL0480001

    Lubin 3092931, 20-093
    Poland

    Site Not Available

  • Investigator Site 18 - ES0340002

    Santiago De Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Investigator Site 18 - ES0340002

    Santiago de Compostela 3109642, A Coruña 15706
    Spain

    Site Not Available

  • Investigator Site 19 - ES0340001

    Barcelona, 08041
    Spain

    Site Not Available

  • Investigator Site 19 - ES0340001

    Barcelona 3128760, 08041
    Spain

    Site Not Available

  • Investigator Site 10 - US0010007

    Carlsbad, California 92011
    United States

    Site Not Available

  • Investigator Site 7 - US0010001

    Orange, California 92868
    United States

    Site Not Available

  • Investigator Site 10 - US0010007

    Carlsbad 5334223, California 5332921 92011
    United States

    Site Not Available

  • Investigator Site 7 - US0010001

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Investigator Site 9 - 0010006

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • Investigator Site 15 - US0010014

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Investigator Site 9 - 0010006

    Boca Raton 4148411, Florida 4155751 33487
    United States

    Site Not Available

  • Investigator Site 15 - US0010014

    Coral Springs 4151909, Florida 4155751 33067
    United States

    Site Not Available

  • Investigator Site 16 - US0010009

    Augusta, Georgia 30910
    United States

    Site Not Available

  • Investigator Site 16 - US0010009

    Augusta 4180531, Georgia 4197000 30910
    United States

    Site Not Available

  • Investigator Site 8 - US0010003

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Investigator Site 6 - US0010008

    Meadows, Illinois 60008
    United States

    Site Not Available

  • Investigator Site 8 - US0010003

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Investigator Site 6 - US0010008

    Meadows 4901810, Illinois 4896861 60008
    United States

    Site Not Available

  • Investigator Site 12 - US0010004

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Investigator Site 12 - US0010004

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Investigator Site 13 - US0010013

    Portland, Oregon 97239
    United States

    Site Not Available

  • Investigator Site 13 - US0010013

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Investigator Site 17 - US0010012

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Investigator Site 17 - US0010012

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Investigator Site 11 - US0010011

    Austin, Texas 78756
    United States

    Site Not Available

  • Investigator Site 11 - US0010011

    Austin 4671654, Texas 4736286 78756
    United States

    Site Not Available

  • Investigator Site 14 - US0010010

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Investigator Site 14 - US0010010

    Richmond 4781708, Virginia 6254928 23219
    United States

    Site Not Available

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