A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy

To join this study, you need to be an adult between 18 and 75 years old and have a clear diagnosis of Multifocal Motor Neuropathy (MMN). You must also currently be receiving treatment with immunoglobulin (Ig) and your dose must have been steady for some time, showing that you respond to this treatment. Additionally, you need to be up-to-date with certain vaccinations, especially those against specific bacteria, following local health guidelines.

There are also some reasons why you might not be able to join. For example, if you have other serious medical conditions or illnesses that could affect the study's results, or if you've recently used certain other medicines like rituximab or similar ones. If you've ever had a specific type of meningitis infection (N. meningitidis) or if you have certain other autoimmune disorders or conditions like HIV, Hepatitis B, or Hepatitis C, you unfortunately wouldn't be able to participate. We will also check your weight to make sure you are between 40 and 120 kilograms.

For female participants who could become pregnant, you must agree to use an effective form of birth control and not try to get pregnant during the study. If you're male and could father a child, you'll also need to agree to use effective birth control or be surgically sterile, and not donate sperm. These measures are in place to ensure your safety and the accuracy of the study results.

If you decide to participate, you'll be randomly assigned to either receive the new study medicine, Claseprubart, or a placebo (a dummy medicine) for a period. This means neither you nor your study doctor will choose which one you get. You will have regular visits to the clinic so the study team can check on your health and any changes in your MMN symptoms. These visits will involve various tests and assessments, such as physical examinations, blood tests, and possibly questionnaires, to see how you are doing and whether the treatment is having an effect.

The study involves several doses of the assigned treatment over time, and the research team will closely monitor you throughout. Your total participation duration will depend on the study design, including the treatment period and follow-up assessments after stopping the treatment. All specific details about the schedule and procedures will be clearly explained to you before you agree to join.