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

Completed · Phase 3

Conditions studied: Generalized Myasthenia Gravis, MG - Myasthenia Gravis, gMG

In brief

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.

Key facts

Study ID

NCT04980495

Run by

argenx

People needed

69

Starts

2021-12-16

Expected to finish

2025-10-06

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age, at the time of signing the informed consent.
• Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs).
• Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, or IV

You may not qualify if…

• Any other condition that, in the opinion of the investigator, would interfere with an accurate assessment of the clinical symptoms of gMG and/or put the participant at undue risk
• A thymectomy within 3 months of screening
• Use of the following prior or concomitant therapies:
• intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) within 14 days of day 1
• Rituximab within 6 months of day 1
• Eculizumab within 1 month of day 1
• Other monoclonal antibodies (eg, adalimumab, tocilizumab, ixekizumab)

Where it is running

• Investigator Site 10 - US0010007 — Carlsbad, California, United States
• Investigator Site 7 - US0010001 — Orange, California, United States
• Investigator Site 9 - 0010006 — Boca Raton, Florida, United States
• Investigator Site 15 - US0010014 — Coral Springs, Florida, United States
• Investigator Site 16 - US0010009 — Augusta, Georgia, United States
• Investigator Site 8 - US0010003 — Chicago, Illinois, United States
• Investigator Site 6 - US0010008 — Meadows, Illinois, United States
• Investigator Site 12 - US0010004 — Kansas City, Kansas, United States
• Investigator Site 13 - US0010013 — Portland, Oregon, United States
• Investigator Site 17 - US0010012 — Philadelphia, Pennsylvania, United States
• Investigator Site 11 - US0010011 — Austin, Texas, United States
• Investigator Site 14 - US0010010 — Richmond, Virginia, United States
• Investigator Site 26 - AT0430002 — Innsbruck, Austria
• Investigator Site 27 - AT0430001 — Vienna, Austria
• Investigator Site 28 - BE0320001 — Leuven, Belgium
• Investigator Site 29 - CA0019003 — London, Canada
• Investigator site 37 - CA0019002 — Québec, Canada
• Investigator Site 23 - FR0330005 — Bordeaux, France
• Investigator Site 24 - FR0330004 — Lille, France
• Investigator Site 20 - FR0330001 — Marseille, France
• Investigator Site 25 - FR0330003 — Nice, France
• Investigator site 38 - FR0330002 — Paris, France
• Investigator Site 2 - GEO9950002 — Tbilisi, Georgia
• Investigator Site 1 - GEO9950001 — Tbilisi, Georgia
• Investigator Site 3 - GEO9950003 — Tbilisi, Georgia

Full record on ClinicalTrials.gov

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