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

NCT06909214 · tracked via the Priya Life Science USA tracker

Sponsor

argenx

Phase

Phase 4

Started

2025-04-17

Last updated

2026-03-10

Condition(s) studied

New Onset Generalized Myasthenia Gravis (gMG)

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SC

Efgartigimod PH20 SC: Subcutaneous injection of efgartigimod PH20 SC

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC — up to 16 weeks
MSE (minimal symptom expression) is defined as an MG-ADL (Myasthenia Gravis Activities of Daily Living) total score of 0 or 1. The MG-ADL scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).

Trial sites (18)

Facility	City	Region	Status
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)	La Jolla	California	Recruiting
Samir Macwan, M.D., Inc. (S corporation)	Rancho Mirage	California	Recruiting
EZR Research	Boca Raton	Florida	Recruiting
University of Florida Jacksonville	Jacksonville	Florida	Recruiting
Visionary Investigators Network	Miami	Florida	Recruiting
University of California Irvine	Orange	Florida	Recruiting
Medsol Clinical Research Center Inc	Port Charlotte	Florida	Recruiting
Baycare Medical Group	St. Petersburg	Florida	Recruiting
Emory Brain Health Center	Atlanta	Georgia	Recruiting
The Queen's Medical Center - West Oahu	Honolulu	Hawaii	Recruiting
Hawaii Pacific Neuroscience	Honolulu	Hawaii	Recruiting
HSHS Medical Group	O'Fallon	Illinois	Recruiting
UMass Memorial Medical Center	Worcester	Massachusetts	Recruiting
Henry Ford Health System	Detroit	Michigan	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
Erlanger Neuroscience Institute	Chattanooga	Tennessee	Recruiting
Central Texas Neurology Consultants - Elligo	Round Rock	Texas	Recruiting
Center for Neurological Disorders - Greenfield	Greenfield	Wisconsin	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06909214 on ClinicalTrials.gov ↗ ← All trials in the USA