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

Last updated: May 2, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Empasiprubart

IVIG (Intravenous Immunoglobulin)

Empasiprubart-placebo

Clinical Study ID

NCT06742190
ARGX-117-2302
2024-516473-72-00
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.

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

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Empasiprubart
Phase: 3
Study Start date:
December 18, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • The Neurology Group

    Pomona, California 91767
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Healthcare Innovations Institute, LLC

    Coral Springs, Florida 33067
    United States

    Active - Recruiting

  • Dent Neurologic Institute Amherst

    Amherst, New York 14226
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas 78759-8402
    United States

    Active - Recruiting

  • NeuroCarePlus

    Houston, Texas 77094
    United States

    Active - Recruiting

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