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A Study Comparing Nipocalimab and Efgartigimod for Adults 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 study involves people with generalized myasthenia gravis, a condition where the immune system attacks the connections between nerves and muscles, causing muscle weakness and tiredness. The study will compare two medications called nipocalimab (also known as JNJ-80202135) and efgartigimod alfa. Both medications work by targeting a specific receptor in the body called the neonatal Fc receptor, which helps reduce certain antibodies that contribute to the disease. The medications will be given through a vein. The purpose of the study is to compare how well nipocalimab works compared to efgartigimod in people who are starting treatment with this type of medication for their myasthenia gravis.

The study will include different groups of people. Some will receive nipocalimab, some will receive efgartigimod, and another group will include people who are already taking efgartigimod and will switch to nipocalimab during the study. People in the study must be adults between 18 and 74 years old and must have specific antibodies called AChR antibodies in their blood. They should also have symptoms that affect more than just their eye muscles and should not be responding well enough to their current treatment.

During the study, the main measurement will look at changes in the levels of a substance called total IgG in the blood between weeks 8 and 12 in those receiving nipocalimab compared to those receiving efgartigimod. The treatment period will last up to several months depending on which group a person is in. The study will help doctors understand whether one medication might work better than the other for treating generalized myasthenia gravis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be assigned to one of three treatment groups. This assignment will determine which medication you receive and how the treatment is administered.

    If you are assigned to arm 1 or arm 2, you will begin treatment with either nipocalimab or efgartigimod alfa as your first medication for managing your condition. These groups are for individuals starting treatment with medications that work through the neonatal Fc receptor, which is a specific way of affecting the immune system.

    If you are assigned to arm 3, this means you have already received at least one cycle of efgartigimod treatment (given either directly into a vein or under the skin) and will be switching to nipocalimab during this study.

  2. Step 2

    Medication administration

    The medication you receive will be given through intravenous use, which means it will be administered directly into a vein.

    If you receive efgartigimod alfa, it will be provided as a solution prepared for injection into your vein.

    If you receive nipocalimab, it will also be administered as a solution through intravenous injection.

    The specific dosage, frequency of administration, and duration of each treatment cycle will be determined according to the study protocol and your assigned treatment group.

  3. Step 3

    Baseline assessment and early treatment period

    At the beginning of the study, baseline measurements will be taken. These measurements serve as a starting point to compare how the treatment affects your condition over time.

    Your total IgG levels will be measured. IgG refers to immunoglobulin G, which is a type of antibody in your blood. The study will track changes in these levels throughout the treatment.

    Your symptoms will be assessed using the MG-ADL scale, which is a tool that measures how your condition affects your daily activities.

  4. Step 4

    Treatment period from week 8 to week 12

    Between week 8 and week 12 of the study, specific measurements will be taken to evaluate how well the treatment is working.

    During this period, your total IgG levels will be monitored regularly to assess the average percent change from your baseline measurements.

    These measurements are a key part of determining the effectiveness of the medication you are receiving.

  5. Step 5

    Ongoing monitoring and assessments

    Throughout the study, regular assessments will be conducted to monitor your response to treatment and to check for any side effects.

    Your healthcare provider will evaluate how your symptoms change over time and how the medication affects your overall condition.

    Blood tests and other evaluations will be performed at scheduled intervals as specified in the study protocol.

  6. Step 6

    Study completion

    The study is expected to continue until approximately April 2027, though your individual participation duration may vary based on the treatment arm you are assigned to and the study protocol.

    Final assessments will be completed to evaluate the overall effect of the treatment on your condition and to gather information about any side effects experienced during the study period.

Who can join the trial?

7 criteria

  • You must be 18 years of age or older and younger than 75 years of age
  • You must have a positive test for AChR antibodies, which are proteins in your blood that can be measured with a blood test
  • Your MG-ADL score must be 5 or higher, with at least half of your symptoms affecting parts of your body other than your eyes. The MG-ADL is a scoring system that measures how much your daily activities are affected by your condition
  • Your doctor must determine that your current treatment for your condition is not working well enough, even though you have been taking it regularly
  • Your blood must show a total IgG level of 6 grams per liter or higher. IgG is a type of protein in your blood that is part of your immune system
  • If you are in a specific treatment group, you must have received at least one complete treatment cycle of a medicine called efgartigimod, given either through a vein or as an injection under the skin
  • If you are in a specific treatment group, both you and your healthcare provider must agree that it is appropriate for you to switch to a different medicine called nipocalimab

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria have been provided for this clinical trial at this time.
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Investigated drugs

  • Nipocalimab

    is a medication being tested for the treatment of generalized myasthenia gravis, a condition that causes muscle weakness. It works by blocking a specific receptor in the body called the neonatal Fc receptor, which helps reduce harmful antibodies that attack the muscles.

  • Efgartigimod

    is another medication used for treating generalized myasthenia gravis. Like nipocalimab, it also works by targeting the neonatal Fc receptor to help lower the levels of antibodies that cause muscle weakness in people with this condition.

What is already known about the treatment

  • Nipocalimab

    Nipocalimab is an experimental medication given through an intravenous infusion (directly into a vein) that is currently being studied in clinical trials for the treatment of generalized myasthenia gravis, a condition where the immune system attacks the connections between nerves and muscles causing muscle weakness. It works by blocking a specific protein called the neonatal Fc receptor, which helps reduce harmful antibodies in the blood that attack the body's own tissues. This medication belongs to a class of drugs known as FcRn blockers or neonatal Fc receptor inhibitors, which represent a newer approach to treating autoimmune diseases by lowering disease-causing antibodies.

  • Efgartigimod

    Efgartigimod is a medication administered through an intravenous infusion that is used to treat generalized myasthenia gravis, an autoimmune disorder characterized by muscle weakness and fatigue. The drug works by binding to the neonatal Fc receptor and triggering the breakdown of harmful antibodies that mistakenly attack the communication points between nerves and muscles. It is classified as an FcRn blocker and has been approved in several countries as a treatment option for patients with this condition. The medication is typically given as a series of infusions over several weeks to help reduce symptoms and improve muscle strength.

Investigated diseases

Generalized Myasthenia Gravis – Generalized myasthenia gravis is a chronic autoimmune disorder that affects the communication between nerves and muscles throughout the body. The immune system produces antibodies that block or destroy the receptors at the connection point between nerves and muscles, preventing normal muscle contraction. This condition causes muscle weakness that typically worsens with activity and improves with rest. The weakness can affect various muscle groups including those controlling eye and eyelid movement, facial expression, chewing, swallowing, and speaking. As the disease progresses, it may also involve muscles that control breathing and movement of the arms and legs. The severity and pattern of muscle weakness can vary significantly between individuals and may fluctuate over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521130-28-00Protocol code80202135MYG3002Estimated enrolment99 patientsSponsorJanssen Cilag International

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