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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: argenx • ClinicalTrials.gov ID: NCT07673627

Registry updated: 2026-10-16
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Description

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life. The aim of this ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG). The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170 More information can be found here: https://clinicaltrials.argenx.com/adaptforward2

Interventions

  • Empasiprubart IV (Biological)
    Intravenous infusions of empasiprubart
  • Placebo IV (Other)
    Intravenous infusions of placebo
  • Efgartigimod PH20 SC PFS (Combination product)
    Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis Myasthenia Gravis (MG) MG - Myasthenia Gravis gMG

Locations

  • Neurology Center of Southern California — Carlsbad, California, United States
  • Visionary Investigators Network — Miami, Florida, United States
  • Profound Research LLC at Las Vegas Neurology Center — Las Vegas, Nevada, United States
  • Dent Neurologic Institute - Amherst — Amherst, New York, United States
  • Erlanger Health System — Chattanooga, Tennessee, United States
  • National Neuromuscular Research Institute — Austin, Texas, United States
  • AHEPA University General Hospital of Thessaloniki — Thessaloniki, Thessaloniki, Greece
  • Hospital Regional Universitario de Malaga - Hospital General — Málaga, Malaga, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record