Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Multifocal Motor Neuropathy (MMN), MMN, Intravenous Immunoglobulins, Empasiprubart, IVIG (Intravenous Immunoglobulin)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 the EFNS/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 a dose 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 for participants receiving IVIg once every 5 weeks)
  • Minimum converted weekly IVIg dose of ≥0.125 g/kg
  • 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

You CAN'T join if...

  • 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
  • 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)

Locations

  • UCSF accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • The Neurology Group accepting new patients
    Pomona 5384170 California 5332921 91767 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
argenx
ID
NCT06742190
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 115 study participants
Last Updated