A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empasiprubart IV.
- Who it may be relevant to
- Registry conditions: Multifocal Motor Neuropathy (MMN). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
Interventions
- Biological Empasiprubart IV
Intravenous infusions of empasiprubart
Primary outcome measures
- 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]
Secondary outcome measures (9)
- Change from baseline in GS in both hands over time [Time frame: Up to 48 weeks]
- Change from baseline in MMN-RODS over time [Time frame: Up to 48 weeks]
- Change from baseline in mMRC-14 sum score over time [Time frame: Up to 48 weeks]
- Percentage change from baseline in time to complete the 9-HPT with both hands over time [Time frame: Up to 48 weeks]
- 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]
- Serum concentrations of empasiprubart over time [Time frame: Up to 60 weeks]
- Percentage change from baseline in free C2 and total C2 over time [Time frame: Up to 60 weeks]
- Incidence of AEs and AESIs [Time frame: Up to 60 weeks]
- Incidence of SAEs [Time frame: Up to 60 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07610564 · ARGX-117-8-MMN-1001 · 2026-525171-20-00