Phase
Condition
N/ATreatment
Empasiprubart
IVIG (Intravenous Immunoglobulin)
Empasiprubart-placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is at least 18 years of age and the local legal age of consent for clinical studies
Has a confirmed diagnosis of definite or probable MMN at screening according to theEFNS/PNS 2010 guidelines
Has responded to IVIg in the past 5 years.
Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and adose of 0.4 to 2.0 g/kg body weight per cycle
Is receiving a maintenance regimen (no change in frequency, and no change in dose >10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks forparticipants receiving IVIg once every 5 weeks)
Minimum converted weekly IVIg dose of ≥0.125 g/kg
Has documented immunization against encapsulated bacterial pathogens (N meningitidisand S pneumoniae) within 5 years of screening or is willing to receive immunizationat least 14 days before first study drug administration
Exclusion
Exclusion Criteria:
Besides the indication under study, known autoimmune disease (eg, SLE) or any othermedical condition that would confound the study results or put the participant atundue risk
Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motorneuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
Study Design
Connect with a study center
The Neurology Group
Pomona, California 91767
United StatesActive - Recruiting
Medstar Health Research Institute
Washington, District of Columbia 20010
United StatesActive - Recruiting
Healthcare Innovations Institute, LLC
Coral Springs, Florida 33067
United StatesActive - Recruiting
Dent Neurologic Institute Amherst
Amherst, New York 14226
United StatesActive - Recruiting
National Neuromuscular Research Institute
Austin, Texas 78759-8402
United StatesActive - Recruiting
NeuroCarePlus
Houston, Texas 77094
United StatesActive - Recruiting
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