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Comparative Efficacy of Nipocalimab and Efgartigimod in Myasthenia Gravis Study ID: 80202135MYG3002 EPIC
EU CTIS ID: 2025-521130-28-00
What this study is testing
To evaluate the efficacy of nipocalimab vs efgartigimod in participants initiating neonatal Fc receptor (FcRn) treatment for generalized myasthenia gravis (gMG).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age and <75 years of age
- AChR antibody positive
- MG-ADL ≥5 with ≥50% as non-ocular
- Has suboptimal response to current stable therapy for generalized Myasthenia Gravis according to the investigator, (specific to arms 1 and 2)
- Total IgG ≥6 g/L, (specific to arms 1 and 2)
- Treatment with efgartigimod intravenously or subcutaneously for ≥1 cycles, (specific to arm 3)
You likely can't join if
- Has received treatment for MG with an FcRn-targeting therapy, (specific to arms 1 and 2)
- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, (specific to arms 1 and 2)
- Current efgartigimod dosing is inconsistent with the label, (specific to arm 3)
See the full eligibility criteria
- ≥18 years of age and <75 years of age
- AChR antibody positive
- MG-ADL ≥5 with ≥50% as non-ocular
- Has suboptimal response to current stable therapy for generalized Myasthenia Gravis according to the investigator, (specific to arms 1 and 2)
- Total IgG ≥6 g/L, (specific to arms 1 and 2)
- Treatment with efgartigimod intravenously or subcutaneously for ≥1 cycles, (specific to arm 3)
- Participant and HCP agree it is appropriate for the participant to switch to nipocalimab, (specific to arm 3)
- Has received treatment for MG with an FcRn-targeting therapy, (specific to arms 1 and 2)
- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, (specific to arms 1 and 2)
- Current efgartigimod dosing is inconsistent with the label, (specific to arm 3)
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.