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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
Sponsorargenx

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Empasiprubart IV

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators