A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

a study on Myasthenia Gravis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Official Title

A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis

Keywords

New Onset Generalized Myasthenia Gravis (gMG), Efgartigimod PH20 SC

Eligibility

You can join if…

Open to people ages 18 years and up

  • Is at least 18 years when signing the ICF
  • Has been diagnosed with gMG of MGFA class II, III, or IV
  • Is seropositive for AChR-Ab
  • Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG
  • Had onset of generalized MG signs and/or symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and/or symptoms within 24 months before screening may be enrolled in the study
  • Has an MG-ADL score ≥5

You CAN'T join if...

  • gMG diagnosis of MGFA class I or V
  • Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis
  • Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG

Locations

  • University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI) accepting new patients
    La Jolla 5363943 California 5332921 92037 United States
  • Samir Macwan, M.D., Inc. (S corporation) accepting new patients
    Rancho Mirage 5386015 California 5332921 92270 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
argenx
ID
NCT06909214
Phase
Phase 4 Myasthenia Gravis Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated