NCT06909214 A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
| NCT ID | NCT06909214 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | argenx |
| Condition | New Onset Generalized Myasthenia Gravis (gMG) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2025-04-17 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06909214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying New Onset Generalized Myasthenia Gravis (gMG). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06909214 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06909214 currently recruiting?
Yes, NCT06909214 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT06909214 trial being conducted?
This trial is being conducted at La Jolla, United States, Rancho Mirage, United States, Boca Raton, United States, Jacksonville, United States and 11 additional locations.
Who is sponsoring the NCT06909214 clinical trial?
NCT06909214 is sponsored by argenx. The trial plans to enroll 30 participants.