NCT06909214RecruitingPhase 4
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
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
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 17 Apr 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- argenx
- Diseases
- Myasthenia gravis
- NCT number
- NCT06909214
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 17 Apr 2025 to the primary completion date, Aug 2026
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- gMG diagnosis of MGFA class I or V
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Brain Health Center Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| EZR Research Coordinator of this site? Confirm its status | Boca Raton | United States | Recruiting |
| Erlanger Neuroscience Institute Coordinator of this site? Confirm its status | Chattanooga | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Center for Neurological Disorders - Greenfield Coordinator of this site? Confirm its status | Greenfield | United States | Recruiting |
| Hawaii Pacific Neuroscience Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| The Queen's Medical Center - West Oahu Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| University of Florida - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI) Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Visionary Investigators Network Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| HSHS Medical Group Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Medsol Clinical Research Center Inc Coordinator of this site? Confirm its status | Port Charlotte | United States | Recruiting |
| Samir Macwan, M.D., Inc. (S corporation) Coordinator of this site? Confirm its status | Rancho Mirage | United States | Recruiting |
| Central Texas Neurology Consultants - Elligo Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Baycare Medical Group Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.