Adding empasiprubart to efgartigimod for AChR-antibody 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

This Phase 2 add-on study enrolls AChR-Ab seropositive participants with generalized myasthenia gravis who complete a run-in period of efgartigimod IV (part A). Eligible participants then enter an add-on period (part B) receiving both efgartigimod IV and empasiprubart IV, while those not eligible proceed to a safety follow-up (part C) receiving efgartigimod alone. The trial is conducted under the ADAPT Forward platform protocol and includes screening, treatment, and follow-up visits over roughly 54 weeks per participant. All participants must meet vaccination requirements for encapsulated bacteria or be willing to be vaccinated before dosing.

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 of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration

Exclusion Criteria:

* Clinical diagnosis of systemic lupus erythematosus (SLE)
* Any known complement deficiency
* Current administration of a complement inhibitor or received zilucoplan or eculizumab \<2 months or ravulizumab \<6 months before the first study drug administration
* Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)

Where it's running

• Profound Research LLC - Carlsbad
  Carlsbad, California, United States Recruiting
• Visionary Investigators Network
  Miami, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Henry Ford Health Systems
  Detroit, Michigan, United States Recruiting
• Profound Research LLC at Las Vegas Neurology Center
  Las Vegas, Nevada, 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.

• 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

• 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

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

  This study tests whether empasiprubart given by IV can help people with AChR-Ab positive generalized myasthenia gravis feel better and have fewer symptoms.

  Recruiting at 14 sites Phase 2 argenx · Carlsbad, California and 13 other locations · NCT07673627

• 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

• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

  This study will try a predefined prednisone taper to see if adults with generalized myasthenia gravis on ravulizumab can safely reduce their daily steroid dose.

  Recruiting Phase 4 Alexion Pharmaceuticals, Inc. · Chicago, Illinois and 11 other locations · NCT07221838

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.