Comparing empasiprubart and IVIg for treating multifocal motor neuropathy in adults

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

Phase 3 Interventional argenx · NCT06742190

This study is testing whether a new treatment called empasiprubart works better than the standard IVIg for adults with multifocal motor neuropathy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment115 (estimated)
Ages18 Years and up
SexAll
Sponsorargenx Industry-sponsored
Locations109 sites (Scottsdale, Arizona and 108 other locations)
Trial IDNCT06742190 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with multifocal motor neuropathy (MMN). It consists of a double-blinded phase where participants receive either empasiprubart or IVIg, followed by an open-label phase where all participants receive empasiprubart. The total duration of participation can last up to 49 months, allowing for thorough assessment of treatment effects. Participants must have a history of responding to IVIg and meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of MMN who have previously responded to IVIg treatment.

Not a fit: Patients with other known autoimmune diseases or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with multifocal motor neuropathy, potentially improving their quality of life.

How similar studies have performed: While there have been studies on IVIg for MMN, the specific comparison with empasiprubart represents a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria
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 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

Exclusion Criteria:

* 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)

Where this trial is running

Scottsdale, Arizona and 108 other locations

+59 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Multifocal Motor NeuropathyMMN
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.