A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy (EmpaSound)

argenx

Status and phase: Not yet enrolling; Phase 1

Conditions: Multifocal Motor Neuropathy (MMN)

Treatments: Biological: Empasiprubart IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07610564

ARGX-117-8-MMN-1001

2026-525171-20-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The main purpose of the study is to evaluate empasiprubart use in adults living with Multifocal Motor Neuropathy (MMN). The researchers will evaluate the effect of empasiprubart on the thickness of the nerves, muscle strength, movement, and on the potential improvement of grip strength of the participants in handling objects.

The study consists of an open-label treatment period where all participants will receive empasiprubart intravenously (IV). After the last dose of empasiprubart participants will enter a safety follow-up period for up to 15 months.

The total study duration for each participant will be approximately 29 months.

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 18 years old
• Diagnosed with MMN
• Has an MMN-RODS centile score of ≤90
• Has confirmed nerve thickening in at least 1 nerve per ultrasound measurement

Exclusion criteria

• Besides the indication under study, known autoimmune disease or any medical condition that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of MMN or puts the participant at undue risk.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Empasiprubart IV

Experimental group

Description:

Participants receive empasiprubart IV

Treatment:

Biological: Empasiprubart IV