ADAPT Forward 2 - ISA2: Empasiprubart for Generalized Myasthenia Gravis

This study is testing a medicine called empasiprubart given through an IV for people with generalized myasthenia gravis (gMG). This is a condition where your immune system mistakenly attacks your body, causing muscle weakness. You may be able to join if you are 18 or older, have gMG that is confirmed by a specific blood test (AChR-Ab seropositive), and meet certain health criteria. The main goal is to see how safe empasiprubart is by tracking any side effects over about 12 weeks. This study is part of a larger effort to find better treatments for gMG. The current status of recruitment is unclear.

Study design
This is an interventional study that plans to enroll 40 participants. Participants will be randomly assigned to receive either empasiprubart IV or a placebo IV, and later all will receive efgartigimod PH20 SC PFS.
What's involved
The study duration for each participant is approximately up to 45 weeks. You would receive intravenous infusions of empasiprubart or placebo, and later subcutaneous injections of efgartigimod PH20.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints are measured up to 12 weeks after treatment. The total study duration for each participant is approximately up to 45 weeks.

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NCT07673627

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

Recruiting
PHASE2Ages 18+InterventionalTreatment
argenx
~40 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Empasiprubart IVPlacebo IVEfgartigimod PH20 SC PFS

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events and serious adverse events in the DBTP
Measured over Up to 12 weeks
AChR-Ab Seropositive Generalized Myasthenia Gravis
Myasthenia Gravis (MG)
MG - Myasthenia Gravis
gMG
2 sites across 2 states
Florida1
Tennessee1

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Eligibility criteria

Inclusion

Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab).
Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb.
Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years before ISA screening or will complete immunization at least 14 days before the first IMP administration.

Exclusion

Clinical diagnosis of systemic lupus erythematosus (SLE).
Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab \>2 months or ravulizumab \>6 months before baseline are allowed to participate.
Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.
Had prior empasiprubart exposure.
  • Incidence of adverse events and serious adverse events in the DBTPUp to 12 weeks