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

Part of paid clinical trials in Carlsbad, California.

Sponsor
argenx
Study ID
NCT04980495
Phase
PHASE3
Status
Completed

Conditions

  • Generalized Myasthenia Gravis
  • MG - Myasthenia Gravis
  • gMG

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusions of efgartigimod

Study Details

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 Dates

Start date
Dec 16, 2021
Status verified
Nov 2025
Primary completion
Aug 24, 2023
Completion
Oct 6, 2025

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod IV - continuous regimen
    Participants receiving efgartigimod IV on a continuous regimen
  • Experimental: Efgartigimod IV - cyclic regimen
    Participants receiving efgartigimod IV on a cyclic regimen

Primary Outcome Measure

Mean of the Average MG-ADL Total Score Change From Baseline During the Visit of Week 1 Through Week 21 by Regimen Arm [ Time Frame: Up to 21 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Investigator Site 10 - US0010007CarlsbadCalifornia92011-
Investigator Site 7 - US0010001OrangeCalifornia92868-
Investigator Site 9 - 0010006Boca RatonFlorida33487-
Investigator Site 15 - US0010014Coral SpringsFlorida33067-
Investigator Site 16 - US0010009AugustaGeorgia30910-
Investigator Site 8 - US0010003ChicagoIllinois60611-
Investigator Site 6 - US0010008MeadowsIllinois60008-
Investigator Site 12 - US0010004Kansas CityKansas66160-
Investigator Site 13 - US0010013PortlandOregon97239-
Investigator Site 17 - US0010012PhiladelphiaPennsylvania19104-
Investigator Site 11 - US0010011AustinTexas78756-
Investigator Site 14 - US0010010RichmondVirginia23219-

Find similar trials in Carlsbad, CA

By research site
Investigator Site 10 - US0010007· Carlsbad, CAInvestigator Site 7 - US0010001· Orange, CAInvestigator Site 9 - 0010006· Boca Raton, FLInvestigator Site 15 - US0010014· Coral Springs, FLInvestigator Site 16 - US0010009· Augusta, GAInvestigator Site 8 - US0010003· Chicago, IL

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