Empasiprubart IV in people with AChR-Ab positive generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ADAPT Forward 2 is a platform trial that tests the safety and efficacy of different therapies for generalized myasthenia gravis. In ISA2, participants who are seropositive for anti-AChR antibodies will be randomized to receive empasiprubart IV or placebo during a double-blind treatment period, followed by open-label efgartigimod for safety follow-up. The total participation per individual is up to about 45 weeks. The study uses standard inclusion criteria for gMG and requires up-to-date vaccination against key encapsulated bacteria. Lead sponsor is argenx, with sites in California, Florida, and Nevada.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neurology Center of Southern California
  Carlsbad, California, United States Recruiting
• Visionary Investigators Network
  Miami, Florida, United States Recruiting
• Profound Research LLC at Las Vegas Neurology Center
  Las Vegas, Nevada, United States Recruiting
• Dent Neurologic Institute - Amherst
  Amherst, New York, United States Recruiting
• Erlanger Health System
  Chattanooga, Tennessee, United States Recruiting
• National Neuromuscular Research Institute
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MG patient registry to track long-term experiences and treatment patterns

  This registry collects information from adults with myasthenia gravis to see how symptoms and quality of life change over time and how treatments relate to those changes.

  Recruiting Autoimmune Neurology Alliance · Framingham, Massachusetts · NCT07761026

• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

  This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.

  Recruiting at 37 sites argenx · Carlsbad, California and 36 other locations · NCT07294170

• Adding empasiprubart to efgartigimod for AChR-antibody positive generalized myasthenia gravis

  This trial will test whether adding empasiprubart to efgartigimod infusions helps people with AChR-antibody positive generalized myasthenia gravis who have only had a partial response to efgartigimod.

  Recruiting at 33 sites Phase 2 argenx · Carlsbad, California and 32 other locations · NCT07284420

• Remote monitoring for adults with myasthenia gravis to see if it works

  This study tests whether continuous remote monitoring and telemedicine exams can help detect MG worsening in adults with MG, aiming to reduce hospital visits.

  Recruiting George Washington University · Washington D.C., District of Columbia · NCT07787247

• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

  This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.

  Recruiting at 8 sites Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07596784

• Impact of efgartigimod on overall disease experience in adults with generalized myasthenia gravis in Italy

  This study looks at real-world use of efgartigimod in adults with generalized myasthenia gravis to see how it affects their daily symptoms and experiences.

  Recruiting at 30 sites argenx · Acquaviva delle Fonti and 29 other locations · NCT07595653

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.