A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
EmpaSound
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
2 other identifiers
interventional
60
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2026
CompletedFirst Posted
Study publicly available on registry
May 28, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
May 28, 2026
May 1, 2026
1.6 years
May 20, 2026
May 20, 2026
Conditions
Outcome Measures
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)
CSA : cross-sectional area
Up to 48 weeks
Secondary Outcomes (9)
Change from baseline in GS in both hands over time
Up to 48 weeks
Change from baseline in MMN-RODS over time
Up to 48 weeks
Change from baseline in mMRC-14 sum score over time
Up to 48 weeks
Percentage change from baseline in time to complete the 9-HPT with both hands over time
Up to 48 weeks
Change from baseline in nerve CSA over time as measured by ultrasound imaging of the median nerve and brachial plexus
Up to 48 weeks
- +4 more secondary outcomes
Study Arms (1)
Empasiprubart IV
EXPERIMENTALParticipants receive empasiprubart IV
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2026
First Posted
May 28, 2026
Study Start
June 30, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
April 1, 2030
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share