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Study on the Effects of Efgartigimod Alfa for Patients with Generalized Myasthenia Gravis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Generalized Myasthenia Gravis (gMG), which is a chronic autoimmune disease that causes muscle weakness. The study is testing a treatment called efgartigimod alfa, which is given through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate how different dosing schedules of efgartigimod alfa can maximize and maintain clinical benefits for patients with gMG.

Participants in the study will receive efgartigimod alfa in one of two dosing regimens. The study will compare a continuous regimen, where the medication is given every two weeks, to a cyclic regimen, where the medication is given in cycles. The study will monitor changes in the participants' symptoms over time to determine which dosing schedule is more effective. The study will also track any side effects or adverse events that participants may experience during the trial.

The trial aims to provide valuable information on how to best use efgartigimod alfa to help manage symptoms of Generalized Myasthenia Gravis. By comparing different dosing regimens, researchers hope to find the most effective way to use this treatment to improve the quality of life for individuals living with this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide signed informed consent, confirming understanding and agreement to follow the study protocol.

    The patient must be at least 18 years old and have a confirmed diagnosis of generalized myasthenia gravis (gMG).

    The patient should meet specific clinical criteria and have a Myasthenia Gravis – Activities of Daily Living (MG-ADL) total score of 5 or more, with more than 50% of the score due to non-ocular symptoms.

  2. Step 2

    Treatment administration

    The patient will receive efgartigimod alfa, administered intravenously as a solution for infusion.

    The dosage is 10 mg per kg of body weight, given in a continuous regimen every two weeks (q2w) or in a cyclic regimen, depending on the study group assignment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's MG-ADL total score will be monitored to assess changes from baseline.

    The primary endpoint is the mean change in the MG-ADL total score from baseline during weeks 1 through 21.

    Secondary endpoints include the incidence and severity of adverse events, changes in laboratory test results, vital signs, and electrocardiogram results.

  4. Step 4

    Study duration

    The study is expected to continue until May 31, 2026.

    The patient will participate in regular visits and assessments throughout the study period to evaluate the clinical efficacy of the treatment.

Who can join the trial?

7 criteria

  • Must be able to provide signed informed consent, which means agreeing to participate after understanding the study details.
  • Must be at least 18 years old at the time of signing the informed consent.
  • Must have been diagnosed with Generalized Myasthenia Gravis (gMG), a condition confirmed by a physical exam and a test showing the presence of specific antibodies called anti-acetylcholine receptor antibodies (AChR-Abs).
  • Must meet the clinical criteria set by the Myasthenia Gravis Foundation of America (MGFA) for class II, III, or IV, which are categories used to describe the severity of the condition.
  • Must have a Myasthenia Gravis – Activities of Daily Living (MG-ADL) total score of 5 or higher at the time of the study, with more than half of the score due to symptoms that are not related to the eyes.
  • Can continue current treatment for gMG, which may include nonsteroidal immunosuppressive drugs (NSIDs), steroids, and/or acetylcholinesterase (AChE) inhibitors. If taking corticosteroids or NSIDs, the dose must be stable for at least 1 month before the study.
  • Must agree to use contraceptive measures as per local regulations. Women who can have children must have a negative blood pregnancy test at the start and a negative urine pregnancy test before receiving the study drug.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Generalized Myasthenia Gravis (gMG) cannot participate. This is a condition that affects the muscles and causes weakness.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the specific health requirements set by the study cannot participate. These requirements ensure the safety and effectiveness of the treatment being tested.
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Investigated drugs

Efgartigimod is a medication being studied for its effectiveness in treating patients with generalized myasthenia gravis. It is administered intravenously and works by modulating the immune system to help reduce the symptoms of this autoimmune condition. The trial is exploring different dosing schedules to determine the best way to maximize and maintain the clinical benefits for patients.

What is already known about the treatment

Efgartigimod – Efgartigimod is administered intravenously, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating Generalized Myasthenia Gravis (gMG). The medication works by reducing the levels of certain antibodies that attack the body's own tissues, thereby alleviating symptoms of the disease. Efgartigimod is classified as an immunomodulatory agent, and its mechanism involves binding to the neonatal Fc receptor, which leads to a decrease in the recycling of immunoglobulin G (IgG) antibodies.

Investigated diseases

Generalized Myasthenia Gravis – Generalized Myasthenia Gravis is a chronic autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It occurs when the immune system mistakenly attacks the body's own tissues, specifically targeting the receptors that receive nerve signals. This results in fluctuating muscle weakness and fatigue, which can affect various muscle groups, including those controlling eye movements, facial expressions, and swallowing. The severity of symptoms can vary widely among individuals and may worsen with physical activity or stress. Over time, the condition can lead to more persistent muscle weakness, impacting daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510932-36-00Protocol codeARGX-113-2003Estimated enrolment68 patientsSponsorArgenx

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