The main purpose of the study is to evaluate empasiprubart use in adults living with Multifocal Motor Neuropathy (MMN). The researchers will evaluate the effect of empasiprubart on the thickness of the nerves, muscle strength, movement, and on the potential improvement of grip strength of the participants in handling objects.
The study consists of an open-label treatment period where all participants will receive empasiprubart intravenously (IV). After the last dose of empasiprubart participants will enter a safety follow-up period for up to 15 months.
The total study duration for each participant will be approximately 29 months.
More information can be found here: clinicaltrials.argenx.com/empasound
Is at least 18 years old
Diagnosed with MMN
Has an MMN-RODS centile score of ≤90
Has confirmed nerve thickening in at least 1 nerve per ultrasound measurement
Besides the indication under study, known autoimmune disease or any medical condition that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of MMN or puts the participant at undue risk.
Single group
Empasiprubart IV
Biological/VaccineIntravenous infusions of empasiprubart
Change from baseline in nerve CSA at week 24 as measured by ultrasound imaging of the median nerve and brachial plexus (individual nerves and average sum score)
CSA : cross-sectional area
Change from baseline in GS in both hands over time
The grip strength (GS) will be measured using a vigorimeter
Change from baseline in MMN-RODS over time
The MMN Rasch-Built Overall Disability Scale (MMN-RODS) is a disease-specific patient-reported outcome instrument that captures activity limitations in patients with MMN. The total raw score will be transformed to a centile score, ranging from 0 (worst outcome) to 100 (best outcome)
Change from baseline in mMRC-14 sum score over time
The modified Medical Research Council (mMRC)-14 is a questionnaire where each muscle group is scored from 0 (paralysis) to 5 (normal strength). A higher value indicates better muscle strength. The total score is based on the sum of both the left and right side of the body
Percentage change from baseline in time to complete the 9-HPT with both hands over time
The 9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and nondominant hands will be tested twice (2 consecutive trials of the dominant hand, followed immediately by 2 consecutive trials of the nondominant hand).
