A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
argenx
Study ID
NCT06298552
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Generalized Myasthenia Gravis
  • Myasthenia Gravis
  • Myasthenia Gravis, Generalized
  • gMG

Eligibility Criteria

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

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusion of efgartigimod
  • Placebo IV — OTHER
    Intravenous infusion of placebo

Study Details

The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 2.5 years.

Key Dates

Start date
Apr 16, 2024
Status verified
Nov 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Efgartigimod IV
    Patients receiving efgartigimod IV in both part A and part B
  • Placebo Comparator: Placebo
    Patients receiving placebo during part A and receiving efgartigimod IV during part B

Primary Outcome Measure

MG-ADL total score change from baseline [ Time Frame: Up to 29 days (part A) ]

Locations (19)

FacilityCityStateZIPSite coordinators
HonorHealth Neurology - Bob Bove Neuroscience InstituteScottsdaleArizona85251-
Loma Linda University HealthFresnoCalifornia93701-2234-
First Choice Neurology Boca RatonBoca RatonFlorida33428-
SFM Clinical Research LLCBoca RatonFlorida33487-
The Neurology Institute / Healthcare Innovations Institute - Coral SpringsCoral SpringsFlorida33067-
Neurology Associates PAMaitlandFlorida32751-
Desai Sethi Medical CenterMiamiFlorida33136-
Medsol Clinical Research Center IncPort CharlotteFlorida33952-
BayCare - St. Anthony's HospitalSt. PetersburgFlorida33705-1410-
University of South Florida (USF) Health - Morsani Center for Advanced HealthcareTampaFlorida33612-
Wellstar - Augusta University Medical CenterAugustaGeorgia30912-
Kansas University Medical Center - Kansas CityFairwayKansas66205-
Rutgers-Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-1962-
University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7025-
Duke University School of Medicine - Duke Early Phase Clinical Research UnitDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Erlanger Neuroscience InstituteChattanoogaTennessee37403-2173-
National Neuromuscular Research InstituteAustinTexas78756-
University of Washington Medical Center - MontlakeSeattleWashington98195-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Neurology - Bob Bove Neuroscience Institute· Scottsdale, AZLoma Linda University Health· Fresno, CAFirst Choice Neurology Boca Raton· Boca Raton, FLSFM Clinical Research LLC· Boca Raton, FLThe Neurology Institute / Healthcare Innovations Institute - Coral Springs· Coral Springs, FLNeurology Associates PA· Maitland, FL

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