A study to evaluate the safety and effectiveness of empasiprubart and efgartigimod alfa in patients with generalized myasthenia gravis.

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What is this study about?

This study is being conducted to evaluate the safety and effectiveness of different treatment approaches for Myasthenia Gravis. This is a rare autoimmune disease where the body’s immune system mistakenly attacks the connection between nerves and muscles, leading to muscle weakness. Specifically, this research focuses on a subtype called AChR-Ab Seropositive Generalized Myasthenia Gravis, which means the disease is present throughout the body and certain antibodies, known as acetylcholine receptor antibodies, can be detected in the blood.

The research involves the use of two medications: efgartigimod alfa and empasiprubart. Both of these are administered through an IV infusion, which is a method of delivering medication directly into a vein. Some participants will receive efgartigimod alfa alone, while others will receive empasiprubart as an additional treatment added to their current efgartigimod alfa therapy. This approach is intended for individuals who have experienced only a partial improvement in their symptoms while using the first medication.

During the study, participants will follow a specific treatment schedule to observe how the medications affect their condition and overall health. Monitoring will include checking vital signs and conducting an ECG, which is a test that records the electrical activity of the heart, to ensure the treatments are tolerated well. The study aims to observe changes in how much the disease impacts daily activities and the severity of muscle weakness over time.

Who Can Join the Study?

  • You must be at least 18 years old or the legal age required to agree to participate in medical studies in your area.
  • You must have been diagnosed with Myasthenia Gravis, a condition that affects how muscles work, with symptoms that match the requirements set by the study doctor.
  • If you are already taking medicines for your condition, such as corticosteroids (steroid medicines that reduce swelling and immune activity), nonsteroidal immunosuppressive drugs (medicines that lower the activity of your immune system), or acetylcholinesterase inhibitors (medicines that help improve communication between nerves and muscles), your dose must be stable, meaning it has not changed recently.
  • You must test seropositive for anti-acetylcholine receptor antibodies, which means your blood contains specific proteins that mistakenly attack the parts of your nerves that control muscle movement.
  • You must have a confirmed diagnosis of generalized Myasthenia Gravis, which is a form of the disease that affects many different muscles throughout the body.
  • Your disease severity must be classified as MGFA Class II, III, IVa, or IVb, which is a scale used by doctors to measure how much the disease affects your muscle strength.
  • You must have proof of vaccination against certain bacteria, specifically Neisseria meningitidis and Streptococcus pneumoniae, within the last 5 years, or you must be willing to get these vaccines at least 14 days before starting the study medication.

Who Cannot Join the Study?

  • You have a known autoimmune disease, which is a condition where your body’s immune system mistakenly attacks your own healthy cells, or any other medical problem that could make it hard to measure your symptoms or put you at extra risk.
  • Your condition is classified as MGFA Class V, which is the most severe stage of Myasthenia Gravis.
  • You have been diagnosed with systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks various parts of the body like skin, joints, or organs.
  • You have any known complement deficiency, which means your body lacks certain proteins in the immune system that help fight infections.
  • You are currently taking a complement inhibitor (a medicine that stops part of the immune system) or have taken zilucoplan or eculizumab within the last 2 months, or ravulizumab within the last 6 months.
  • You have been found to be refractory to efgartigimod, meaning the medicine efgartigimod did not work for you because you did not see an improvement of at least 2 points on the MG-ADL score, which is a scale used to measure how much your daily activities are affected by your symptoms.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Eginitio Hospital Athens Greece
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Linrs Uiynnqdopehp Mycewfa Clwbaay (oodff Leiden The Netherlands
Mmuxlfcdf Iqrsknqlfr Cvqzrfeg Slbmgxus Szx z oakr Warsaw Poland
Hiagfmgz Dj Ln Szana Cgyl I Spvr Pru Barcelona Spain
Ajfcblf Ojfiicplyek Pzwp Guqozsrp Xfhpk Bergamo Italy
Uyixtevbkqrckwmgnnnot Weqxnozuh Aul Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.03.2026
Germany Germany
Not yet recruiting
15.03.2026
Greece Greece
Not yet recruiting
15.03.2026
Italy Italy
Recruiting
15.03.2026
Poland Poland
Recruiting
15.03.2026
Spain Spain
Recruiting
15.03.2026
The Netherlands The Netherlands
Recruiting
15.03.2026

Trial locations

Empasiprubart is an experimental medicine given through a vein (IV infusion) that is being studied to see if it can help improve symptoms in people with myasthenia gravis, specifically when used alongside another treatment.

Efgartigimod alfa is a treatment given through a vein (IV infusion) used to help manage myasthenia gravis by targeting specific parts of the immune system.

Investigated diseases:

Generalized Myasthenia Gravis – This is an autoimmune disorder where the body’s immune system mistakenly attacks the communication points between nerves and muscles. This attack leads to weakness in various muscle groups throughout the body. The condition typically causes fluctuating muscle weakness that worsens with physical activity and improves with rest. Symptoms often involve the eyes, face, throat, and limbs. As the disease progresses, the weakness can spread to different parts of the body.

Trial ID:
2025-522492-28-00
Protocol code:
ARGX-999-2-MG-20001
Trial Phase:
Therapeutic exploratory (Phase II)

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