NIPH Clinical Trials Search

A study to assess the efficacy and safety of Empasiprubart versus IVIg in adults with Multifocal Motor Neuropathy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Multifocal Motor Neuropathy
Date of first enrollment	07/07/2025
Target sample size	6
Countries of recruitment	United States,Japan,Canada,Japan,United Kingdom,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,Estonia,Japan,France,Japan,Germany,Japan,Italy,Japan,Korea,Japan,Latvia,Japan,Lithuania,Japan,Poland,Japan,Netherlands,Japan,Portugal,Japan,Serbia,Japan,Spain,Japan,Sweden,Japan,Slovakia,Japan,Slovenia,Japan,Switzerland,Japan,Greece,Japan,Norway,Japan
Study type	Interventional
Intervention(s)	In part A, participants will be randomized to the empasiprubart group or the IVIg group in a 2:1 ratio to 1 of 2 arms. In empasiprubart group, empasiprubart will be administered intravenously (IV) plus IVIg placebo. In IVIg group, empasiprubart placebo plus IVIg will be administered. IVIg or IVIg placebo will be administered according to the participant's established regimen before study entry. In part B (a 24-month open-label extension period), all participants will receive empasiprubart IV.

Outcome(s)

Primary Outcome	To demonstrate the efficacy of empasiprubart compared to intravenous immunoglobulin (IVIg) in improving muscle strength
Secondary Outcome	To demonstrate the efficacy of empasiprubart compared to IVIg on functional ability To demonstrate the efficacy of empasiprubart compared to IVIg on motor function To demonstrate the efficacy of empasiprubart compared to IVIg on manual dexterity

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. 2. Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines and confirmed by the MCC. 3. Has responded to IVIg in the past 5 years. 4. Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle. 5. Minimum converted weekly IVIg dose of >= 0.125 g/kg. 6. Is receiving an optimal IVIg maintenance regimen (as assessed by the investigator, with no changes in frequency, and no change in dose >10%) for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks) and will receive the same regimen until baseline (day 1) with at least 2 recorded IVIg cycles during screening. The maintenance regimen will be confirmed by the MCC. 7. Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first IMP administration.
Exclude criteria	1. Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition (eg, diabetic neuropathy, CIDP, inflammatory arthritis, or osteoarthritis affecting the hand) that would confound the study results or put the participant at undue risk 2. Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)