This study focuses on adults with Multifocal Motor Neuropathy, a rare neurological condition that affects motor nerves and causes progressive muscle weakness. The research compares two treatments: a new medication called empasiprubart and standard therapy with intravenous immunoglobulin (a treatment made from donated blood plasma that contains antibodies). The study will also use placebo solutions for comparison purposes.
The main purpose of this research is to determine if empasiprubart is effective at improving muscle strength compared to intravenous immunoglobulin in people with Multifocal Motor Neuropathy. Both medications will be given through intravenous infusion, which means they are administered directly into a vein.
The study is divided into two parts. During the treatment period, participants will receive either empasiprubart or intravenous immunoglobulin along with their matching placebos. Throughout the study, doctors will measure changes in muscle strength and other aspects of the condition. The research team will also monitor the safety of the treatments and collect information about how well participants feel and function in their daily activities.
1Initial phase preparation
Before starting treatment, you will receive vaccinations against bacterial infections (N. meningitidis and S. pneumoniae) if you haven’t had them in the past 5 years
The vaccination must be completed at least 14 days before starting the study medication
2Treatment period – Part A
The study will compare two treatments: empasiprubart and intravenous immunoglobulin (IVIg)
You will receive treatment through intravenous infusion (medication given directly into a vein)
The treatment period lasts 24 weeks
Your muscle strength will be measured regularly, with special attention to hand strength
Various assessments will be performed, including tests of hand function and daily activities
Blood samples will be taken to monitor medication levels and immune system response
3Monitoring and assessments
Regular checks of vital signs and heart activity (ECG)
Laboratory tests to monitor your health status
Assessment of fatigue levels and quality of life
Evaluation of hand function using specific tests
Regular monitoring of any side effects or reactions to the treatment
4Extended observation – Part B
Continued monitoring of muscle strength and hand function
Ongoing assessment of daily activities and quality of life
Regular blood tests to check medication levels
Continued monitoring of side effects and safety
Who Can Join the Study?
Must be at least 18 years old and able to legally consent to participate in clinical studies
Must have a confirmed diagnosis of Multifocal Motor Neuropathy (MMN), either definite or probable, according to established medical guidelines
Must have shown positive response to IVIg treatment (intravenous immunoglobulin – a treatment given through a vein) within the past 5 years
Must currently be receiving IVIg treatment every 2, 3, 4, or 5 weeks, with a dose between 0.4 to 2.0 grams per kilogram of body weight per treatment cycle
Must be on a stable IVIg treatment plan for at least 8 weeks before screening (or 10 weeks for those receiving treatment every 5 weeks), with no major changes in frequency or dose
Must receive a minimum weekly IVIg dose of at least 0.125 grams per kilogram of body weight
Must either have received vaccines against certain bacteria (N. meningitidis and S. pneumoniae) within the past 5 years, or be willing to get vaccinated at least 14 days before starting the study medication
Who Cannot Join the Study?
History of severe allergic reactions to immunoglobulin treatments (antibody-based medications given through IV)
Presence of other neurological conditions that could affect muscle strength assessment
Active infections or severe illnesses that could interfere with study participation
Previous treatment with experimental medications within 3 months before the study
Pregnancy or breastfeeding
Significant kidney or liver disease
History of blood clotting disorders
Uncontrolled high blood pressure
Recent surgery within the past 3 months
Current participation in other clinical trials
Known immunodeficiency conditions (weakened immune system)
History of cancer within the past 5 years
Severe mental health conditions that could affect ability to follow study procedures
Empasiprubart is an investigational medication being studied for treating multifocal motor neuropathy, a rare neurological condition that affects muscle strength. This medication is being developed as a potential alternative to current treatments.
Intravenous Immunoglobulin (IVIg) is a treatment made from donated blood plasma that contains healthy antibodies. It is given through a vein and is currently used as a standard treatment for multifocal motor neuropathy. IVIg helps reduce inflammation and supports the immune system to improve muscle strength in patients with this condition.
Multifocal Motor Neuropathy – A rare neurological disorder that affects multiple motor nerves in the body. The condition causes progressive muscle weakness, primarily affecting the arms and hands, though it can also impact the legs. The weakness typically begins on one side of the body and gradually spreads to affect multiple areas. The disease specifically targets motor nerves while leaving sensory nerves intact, which distinguishes it from other neurological conditions. Muscle weakness is often accompanied by muscle cramping and uncontrolled twitching.
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