Study on the Effects of Inebilizumab for Adults with Myasthenia Gravis

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

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
Hospital Del Mar Barcelona Spain
Mtz Clinical Research Powered By Pratia Warsaw Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Gornoslaskie Centrum Mwdyczne Katowice Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Med Polonia Sp. z o.o. Poznan Poland
Centre Hospitalier Universitaire De Nice Nice France
Uddconyowoqmuoemvzxpd Ecnae Anz Essen Germany
Hxqgntbz Uiusyztlleqcn Hycbhsxg Teiqc y Pecfak Iqngzbyv Cwkzbp dmdckliciuhkumotm (wiik Badalona Spain
Hfcqbgdi Unywlzbkazitgp Shswskaczc &teflnq Hysavwm dz Hhvobcouvvd STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
03.08.2020
Germany Germany
Not recruiting
03.08.2020
Italy Italy
Not recruiting
03.08.2020
Poland Poland
Not recruiting
03.08.2020
Spain Spain
Not recruiting
03.08.2020

Trial locations

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.

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 ID:
2023-510006-40-00
Protocol code:
VIB0551.P3.S1
NCT ID:
NCT04524273
Trial Phase:
Therapeutic confirmatory (Phase III)

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