This study is looking at chronic inflammatory demyelinating polyneuropathy, which is a condition that affects the nerves outside the brain and spinal cord. In this condition, the protective covering of the nerves becomes damaged due to ongoing inflammation, leading to weakness, numbness, and difficulties with movement and daily activities. The study will compare two different treatments given through a vein. One treatment is empasiprubart, also called ARGX-117, which is a laboratory-made protein designed to block a specific part of the immune system that may contribute to nerve damage. The other treatment is human normal immunoglobulin given through a vein, which is a blood product containing antibodies that is already used to treat this condition. Some participants will receive placebo, which is an inactive substance that looks like the real treatment but contains no active medicine.
The purpose of this study is to show whether empasiprubart works better than human normal immunoglobulin in improving the ability to perform daily activities in adults with this nerve condition. During the study, participants will be randomly assigned to receive either empasiprubart or human normal immunoglobulin through a vein. The study uses a double-dummy design, which means that all participants will receive two infusions to ensure that neither the participants nor the doctors know which treatment is being given. The main assessment will happen at week 24, when doctors will measure changes in functional ability using a scoring system that evaluates arm and leg function.
Throughout the study, various measurements will be taken to assess how well participants can perform daily tasks, their muscle strength, their walking ability, and their overall quality of life. Grip strength will be measured regularly, and participants will complete questionnaires about their disability, fatigue, pain, and general health status. Blood samples will be taken to measure drug levels and to check for any immune responses to the treatment. Safety will be monitored by tracking any unwanted effects, changes in laboratory tests, heart rhythm recordings, and vital signs. The study will also look at how the treatments affect specific proteins in the blood that are involved in the immune response and nerve damage.



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