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An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
Sponsor: argenx
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.
Official title: A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2021-12-16
Completion Date
2025-10-06
Last Updated
2026-05-27
Healthy Volunteers
No
Interventions
Efgartigimod IV
Intravenous infusions of efgartigimod
Locations (39)
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
Investigator Site 33 - DE0490004
Berlin, Germany
Investigator Site 36 - DE0490002
Bochum, Germany
Investigator Site 32 - DE0490001
Essen, Germany
Investigator Site 34 - DE0490005
Hanover, Germany
Investigator Site 31 - IT0390005
Bologna, Italy
Investigator Site 30 - IT0390004
Genova, Italy
Investigator Site 21 - IT0390002
Milan, Italy
Investigator site 39 - IT0390006
Pisa, Italy
Investigator Site 22 - IT0390001
Roma, Italy
Investigator Site 35 - NL0310001
Amsterdam, Netherlands
Investigator Site 5 - PL0480002
Krakow, Poland
Investigator Site 4 - PL0480001
Lubin, Poland
Investigator Site 18 - ES0340002
Santiago de Compostela, A Coruña, Spain
Investigator Site 19 - ES0340001
Barcelona, Spain