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

argenx

Status and phase

Enrolling

Phase 4

Conditions

New Onset Generalized Myasthenia Gravis (gMG)

Treatments

Biological: Efgartigimod PH20 SC

Study type

Interventional

Funder types

Industry

Identifiers

NCT06909214

ARGX-113-2407

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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