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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multifocal Motor Neuropathy (MMN), MMN

In brief

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. More information can be found here: https://clinicaltrials.argenx.com/empassion

Key facts

Study ID

NCT06742190

Run by

argenx

People needed

154

Starts

2024-12-18

Expected to finish

2029-12-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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)

Where it is running

• The Neurology Group — Pomona, California, United States
• Samir Macwan, M.D., Inc. — Rancho Mirage, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic) — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Medstar Health Research Institute — Washington D.C., District of Columbia, United States
• EZR Research LLC — Boca Raton, Florida, United States
• Healthcare Innovations Institute, LLC — Coral Springs, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Fairway, Kansas, United States
• Perelman Center for Advanced Medicine — Columbia, Maryland, United States
• UC Irvine - MDA ALS and Neuromuscular Center — Columbia, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Dent Neurologic Institute Amherst — Amherst, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Morrisville, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• National Neuromuscular Research Institute — Austin, Texas, United States
• NeuroCarePlus — Houston, Texas, United States
• Royal Melbourne Hospital — Parkville, Australia
• HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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