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Study on the Effectiveness and Safety of Efgartigimod in Adults with Ocular Myasthenia Gravis

Fast replyRegistered 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 Ocular Myasthenia Gravis, which affects the muscles around the eyes, leading to weakness and fatigue. The study will evaluate a treatment called Efgartigimod, also known by its code name ARGX-113. Efgartigimod is administered as a solution for injection using a pre-filled syringe. The trial will compare the effects of Efgartigimod with a placebo, which is a substance with no active medication, to determine its effectiveness and safety in treating this condition.

The purpose of the study is to assess how well Efgartigimod works in improving symptoms of Ocular Myasthenia Gravis and to ensure it is safe for use. Participants in the study will receive either Efgartigimod or a placebo through subcutaneous injection, which means the injection is given under the skin. The study will monitor changes in the participants' symptoms over a period of time, focusing on improvements in muscle strength around the eyes and overall well-being.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The trial aims to provide valuable information on the potential benefits of Efgartigimod for individuals with Ocular Myasthenia Gravis, contributing to the development of effective treatments for this condition. The study is designed to ensure the safety and well-being of all participants while gathering important data on the treatment's impact.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, diagnosis of myasthenia gravis, and certain test results.

    Participants must be at least 18 years old and have a confirmed diagnosis of ocular myasthenia gravis.

  2. Step 2

    Treatment phase

    Participants receive either efgartigimod or a placebo through a subcutaneous injection. This means the injection is given under the skin.

    The medication is provided in a pre-filled syringe, ensuring accurate dosage and ease of administration.

  3. Step 3

    Monitoring and assessment

    Throughout the study, participants' ocular symptoms are monitored using the MGII (PRO) ocular score. This score helps assess changes in symptoms from the start of the study to day 29.

    Additional assessments include changes in MG-ADL ocular domain scores and other related scores to evaluate the impact of the treatment.

  4. Step 4

    Safety evaluations

    The study includes regular checks for any adverse effects or serious adverse effects that may occur during the treatment.

    Participants undergo routine laboratory tests, vital sign checks, and ECGs to ensure safety throughout the study.

  5. Step 5

    Completion of the study

    The study is expected to conclude by April 2028, with ongoing assessments and data collection until that time.

    Final evaluations will include a comprehensive review of all collected data to determine the efficacy and safety of the treatment.

Who can join the trial?

4 criteria

  • The person must be at least 18 years old and meet the legal age of consent for clinical studies in their area.
  • The person must have been diagnosed with **myasthenia gravis**, a condition that affects the muscles, and this diagnosis should be supported by a positive test for **AChR-Ab** (a specific antibody related to the condition) or by showing abnormal results in tests that check how nerves and muscles work together. They should also have a history of improvement with **MG therapy**, which is treatment for myasthenia gravis.
  • The person should be classified as **MGFA Class I**, which means they have weakness in the muscles around the eyes.
  • The person must have a score of at least 6 on the **MGII (PRO) ocular score**, which is a way to measure the severity of eye muscle weakness, with at least 2 items related to the eyes scoring at least 2.

Who cannot join the trial?

10 criteria

  • Participants with any other serious health condition that could interfere with the study.
  • Individuals who have had a recent infection or illness that could affect the study results.
  • People who are currently taking medications that might interfere with the study treatment.
  • Participants who have a history of allergic reactions to similar treatments.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Participants with a history of drug or alcohol abuse.
  • Individuals who have had a recent surgery or are planning to have surgery during the study.
  • People with a history of certain eye conditions that could affect the study.
  • Participants who are unable to comply with the study procedures or follow-up visits.
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Investigated drugs

Efgartigimod PH20 SC is a medication being studied for its effectiveness and safety in treating adults with ocular myasthenia gravis, a condition that affects the muscles around the eyes. This medication is administered using a prefilled syringe and is designed to help improve muscle strength and reduce symptoms associated with this condition.

What is already known about the treatment

Efgartigimod PH20 SC – This medication is administered subcutaneously using a prefilled syringe. It is currently being studied in a Phase 3 clinical trial to evaluate its effectiveness and safety for treating Ocular Myasthenia Gravis, a condition that affects eye muscles. Efgartigimod works by modulating the immune system to reduce the levels of antibodies that attack the body's own tissues, thereby alleviating symptoms. It is classified as an immunomodulatory agent.

Investigated diseases

Ocular Myasthenia Gravis – This is a chronic autoimmune disorder that primarily affects the muscles controlling eye and eyelid movement, leading to weakness and fatigue. The condition is characterized by drooping of one or both eyelids (ptosis) and double vision (diplopia), which may fluctuate in severity throughout the day. Symptoms often worsen with activity and improve with rest. Unlike generalized myasthenia gravis, ocular myasthenia gravis does not typically affect other muscle groups. The progression of the disease can vary, with some individuals experiencing stable symptoms, while others may develop generalized myasthenia gravis over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514133-38-00Protocol codeARGX-113-2315Estimated enrolment267 patientsSponsorArgenx

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