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

Conditions

• MMN
• Multifocal Motor Neuropathy (MMN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empasiprubart — BIOLOGICAL
  Intravenous infusion of empasiprubart
• IVIG (Intravenous Immunoglobulin) — BIOLOGICAL
  Intravenous infusion of IVIg
• Empasiprubart-placebo — OTHER
  A placebo resembling the empasiprubart treatment
• IVIg-placebo — OTHER
  A placebo resembling the IVIg treatment

Study Details

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 Dates

Start date

Dec 18, 2024

Status verified

Apr 2026

Primary completion

Sep 30, 2026

Completion

Dec 31, 2029

Study Design

Enrollment

154 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A - empasiprubart + IVIg-placebo
  During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm
• Active Comparator: Part A - IVIg + empasiprubart-placebo
  During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm
• Experimental: Part B - empasiprubart
  After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)

Primary Outcome Measure

Change from baseline in grip strength (4-week average) in the most affected hand at week 24 [ Time Frame: Up to 24 weeks ]

Locations (24)

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