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NCT06909214 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
A Phase 4 study of New Onset Generalized Myasthenia Gravis (gMG), sponsored by argenx.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 18
- Study locations
NCT06909214: Recruiting Phase 4 study of New Onset Generalized Myasthenia Gravis (gMG), sponsored by argenx.
NCT06909214 is a Phase 4 study of New Onset Generalized Myasthenia Gravis (gMG) that is actively recruiting participants, run by argenx. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06909214, a Phase 4 study of New Onset Generalized Myasthenia Gravis (gMG), is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod PH20 SC
Study Locations (18)
Florida
- EZR Research - Boca Raton
- University of Florida Jacksonville - Jacksonville
- Visionary Investigators Network - Miami
- University of California Irvine - Orange
- Medsol Clinical Research Center Inc - Port Charlotte
- Baycare Medical Group - St. Petersburg
California
- University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI) - La Jolla
- Samir Macwan, M.D., Inc. (S corporation) - Rancho Mirage
Hawaii
- The Queen's Medical Center - West Oahu - Honolulu
- Hawaii Pacific Neuroscience - Honolulu
Georgia
- Emory Brain Health Center - Atlanta
Illinois
- HSHS Medical Group - O'Fallon
Massachusetts
- UMass Memorial Medical Center - Worcester
Michigan
- Henry Ford Health System - Detroit
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2027-05 |
| Phase | Phase 4 |
What NCT06909214 shows while recruiting
NCT06909214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with New Onset Generalized Myasthenia Gravis (gMG) appearing as the primary indexed condition, and to 1 intervention - of which Efgartigimod PH20 SC is the first listed.
NCT06909214 lists 18 locations in 11 states (Florida, California, Hawaii).
Frequently Asked Questions
What is clinical trial NCT06909214 about?
NCT06909214 is a clinical study titled "A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)". 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 p...
What is the current status of trial NCT06909214?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2025-04-17. Estimated completion is 2027-05.
What conditions does trial NCT06909214 study?
This clinical trial studies the following conditions: New Onset Generalized Myasthenia Gravis (gMG).
What interventions are being tested in trial NCT06909214?
The interventions under investigation include: Efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT06909214?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06909214 being conducted?
This trial has 18 study locations across California, Florida, Georgia, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06909214's enrollment target sits among peer trials
30 1552nd of 2000 higher than 368 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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