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NCT Number: NCT07610564

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

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

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Key information

Conditions

Multifocal Motor Neuropathy (MMN)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empasiprubart IV

Biological

Intravenous infusions of empasiprubart

Primary outcomes

  1. Change from baseline in nerve CSA at week 24 as measured by ultrasound imaging of the median nerve and brachial plexus (individual nerves and average sum score)

    Time frame: Up to 48 weeks

    CSA : cross-sectional area

Secondary outcomes

  1. Change from baseline in GS in both hands over time

    Time frame: Up to 48 weeks

    The grip strength (GS) will be measured using a vigorimeter

  2. Change from baseline in MMN-RODS over time

    Time frame: Up to 48 weeks

    The MMN Rasch-Built Overall Disability Scale (MMN-RODS) is a disease-specific patient-reported outcome instrument that captures activity limitations in patients with MMN. The total raw score will be transformed to a centile score, ranging from 0 (worst outcome) to 100 (best outcome)

  3. Change from baseline in mMRC-14 sum score over time

    Time frame: Up to 48 weeks

    The modified Medical Research Council (mMRC)-14 is a questionnaire where each muscle group is scored from 0 (paralysis) to 5 (normal strength). A higher value indicates better muscle strength. The total score is based on the sum of both the left and right side of the body

  4. Percentage change from baseline in time to complete the 9-HPT with both hands over time

    Time frame: Up to 48 weeks

    The 9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and nondominant hands will be tested twice (2 consecutive trials of the dominant hand, followed immediately by 2 consecutive trials of the nondominant hand).

  5. Change from baseline in nerve CSA over time as measured by ultrasound imaging of the median nerve and brachial plexus

    Time frame: Up to 48 weeks

    CSA : cross-sectional area

  6. Serum concentrations of empasiprubart over time

    Time frame: Up to 60 weeks

  7. Percentage change from baseline in free C2 and total C2 over time

    Time frame: Up to 60 weeks

    C2 : complement component 2

  8. Incidence of AEs and AESIs

    Time frame: Up to 60 weeks

    AE : adverse event ; AESI : adverse event of special interest

  9. Incidence of SAEs

    Time frame: Up to 60 weeks

    SAE : Serious adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

An Open-Label, Single-Arm, Phase 1b Study to Evaluate the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy

Acronym: EmpaSound

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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