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

Description

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.

Conditions

Multifocal Motor Neuropathy (MMN)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Multifocal Motor Neuropathy (MMN)
Intervention / Treatment

-

Contacts and Locations

Amherst

Dent Neurologic Institute Amherst, Amherst, New York, United States, 14226

Austin

National Neuromuscular Research Institute, Austin, Texas, United States, 78759-8402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

argenx,

Study Record Dates

2029-12