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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

RecruitingPhase 2Ages 18 Years - anyAllargenx
NCT07673627 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Empasiprubart IV
  • Placebo IV
  • Efgartigimod PH20 SC PFS
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Where

8 sites
Neurology Center of Southern California
Carlsbad, United States
Visionary Investigators Network
Miami, United States
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, United States
Dent Neurologic Institute - Amherst
Amherst, United States
Erlanger Health System
Chattanooga, United States
National Neuromuscular Research Institute
Austin, United States
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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