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A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Mot

Neurology
Jeffrey Mullen
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
Brain - Neurologic/ Psychologic
Neuromuscular Diseases

Study Description

Eligibility

  1. Is at least 18 years of age and the local legal age of consent for clinical studies
  2. Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
  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. Is receiving a maintenance regimen (no change in frequency, and no change in dose greater than 10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
  6. Minimum converted weekly IVIg dose of greater than or equal to 0.125 g/kg
  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 study drug administration
  1. Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition 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)
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