NCT06742190

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multifocal Motor Neuropathy (MMN)
• MMN

Interventions

Type	Name	Description
BIOLOGICAL	Empasiprubart	Intravenous infusion of empasiprubart
BIOLOGICAL	IVIG (Intravenous Immunoglobulin)	Intravenous infusion of IVIg
OTHER	Empasiprubart-placebo	A placebo resembling the empasiprubart treatment
OTHER	IVIg-placebo	A placebo resembling the IVIg treatment

Timeline

• Start date: 2024-12-18
• Primary completion: 2026-09-01
• Completion: 2029-12-01
• First posted: 2024-12-19
• Last updated: 2026-03-13

Locations

109 sites across 26 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study