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Study on the Effects of Inebilizumab for Adults with 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 the effects of a treatment called inebilizumab on a condition known as myasthenia gravis. Myasthenia gravis is a disease that causes weakness in the muscles, and it can be due to specific antibodies, which are proteins in the body that mistakenly attack healthy cells. These antibodies are called acetylcholine receptor antibodies (AChR) or muscle-specific kinase antibodies (MuSK). The treatment being tested, inebilizumab, is given as an injection into a vein, and it is being studied to see if it can help reduce the disability caused by myasthenia gravis.

The study is designed to compare the effects of inebilizumab with a placebo, which is a substance with no active medication. Participants in the study will receive either inebilizumab or the placebo. The study will last for a period of time, during which participants will receive regular doses of the treatment. The goal is to observe any changes in the participants' ability to perform daily activities and to assess the overall safety and effectiveness of inebilizumab.

Throughout the study, participants will be monitored for any side effects or changes in their condition. The study will also look at how inebilizumab affects the use of other medications, such as corticosteroids, which are often used to manage myasthenia gravis. By the end of the study, researchers hope to determine if inebilizumab can provide a meaningful improvement in the lives of those living with myasthenia gravis.

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 related to Myasthenia Gravis (MG). This includes having certain antibodies and a specific score on the MG Activities of Daily Living (MG-ADL) scale.

    Participants must be on a stable dose of corticosteroids or a non-steroidal immunosuppressive therapy (IST) for a specified period before starting the trial.

  2. Step 2

    Initial treatment phase

    The treatment involves receiving inebilizumab, administered through an intravenous infusion. The solution contains specific components to maintain its stability and effectiveness.

    The primary goal during this phase is to assess the reduction in MG-related disability by monitoring changes in the MG-ADL score.

  3. Step 3

    Monitoring and assessment

    Participants are monitored for changes in their condition, specifically looking at the MG-ADL and Quantitative Myasthenia Gravis (QMG) scores at Week 26.

    Safety and tolerability of the treatment are evaluated by tracking any adverse events and conducting laboratory tests.

  4. Step 4

    Open-label period

    After the initial phase, participants may enter an open-label period where they continue to receive inebilizumab.

    Further assessments are conducted at Week 52 to evaluate long-term effects and any changes in medication dosage, such as corticosteroid reduction.

  5. Step 5

    Completion and follow-up

    The study is expected to conclude by November 2027. Participants' progress and any long-term effects of the treatment are documented.

    Final assessments include evaluating the overall improvement in MG symptoms and quality of life.

Who can join the trial?

6 criteria

  • The patient must have a diagnosis of Myasthenia Gravis (MG) with specific antibodies called anti-AChR or anti-MuSK.
  • The patient should be classified as Class II, III, or IV according to the MGFA Clinical Classification, which is a way to describe the severity of MG.
  • The patient must have an MG-ADL score between 6 and 10, with more than 50% of this score related to symptoms other than eye problems, or a score of 11 or higher. The MG-ADL score measures how MG affects daily activities.
  • The patient must have a QMG score of 11 or higher. The QMG score is a way to measure the strength and function of muscles in people with MG.
  • The patient must be taking certain medications: either corticosteroids without increasing the dose in the last 4 weeks, or one allowed non-steroidal immunosuppressive therapy (IST) for at least 6 months without increasing the dose in the last 4 months, or a combination of both. Allowed ISTs include azathioprine, mycophenolate mofetil, and mycophenolic acid.
  • Females who can have children and are sexually active with a male partner must use at least one highly effective method of birth control from the time of screening and for 6 months after the last dose of the study medication. Methods like periodic abstinence, the rhythm method, or withdrawal are not acceptable.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to similar medications.
  • Patients who are currently pregnant or breastfeeding.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who are unable to follow the study procedures or attend scheduled visits.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have received certain treatments for Myasthenia Gravis recently.
  • Patients with infections that are not well controlled.
  • Patients with a compromised immune system, meaning their body's defense against infections is weakened.
  • Patients who have been diagnosed with cancer in the past five years, except for some skin cancers.
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Investigated drugs

Inebilizumab is a medication being studied for its potential to help reduce disability related to myasthenia gravis, a condition that causes muscle weakness. It works by targeting specific cells in the immune system that may be involved in the disease process. The trial aims to determine if this medication can improve symptoms and provide a safer treatment option for adults with myasthenia gravis.

What is already known about the treatment

Inebilizumab – Inebilizumab is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating Myasthenia Gravis, a condition characterized by muscle weakness due to antibodies affecting nerve-muscle communication. It is classified as a monoclonal antibody and works by targeting and depleting specific immune cells that contribute to the disease. The medication is in the advanced stages of clinical research, with ongoing studies evaluating its safety and ability to reduce symptoms associated with Myasthenia Gravis.

Investigated diseases

Myasthenia Gravis – 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 produces antibodies that block or destroy muscle receptor sites for a neurotransmitter called acetylcholine. This disruption prevents muscles from contracting properly, causing symptoms such as drooping eyelids, double vision, and difficulty swallowing. The severity of muscle weakness can vary, often worsening with activity and improving with rest. In some cases, the disease is associated with antibodies against muscle-specific kinase (MuSK), which can lead to more severe symptoms. The progression of the disease can fluctuate, with periods of improvement and worsening.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510006-40-00Protocol codeVIB0551.P3.S1Estimated enrolment230 patientsSponsorHorizon Therapeutics Ireland Designated Activity Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).