Multifocal Motor Neuropathy (MMN)Phase 1EmpaSoundNCT07610564
A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
A Phase 1 study testing Empasiprubart IV in people with Multifocal Motor Neuropathy (MMN), run by argenx at 4 sites in Georgia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multifocal Motor Neuropathy (MMN)
- What is being tested?
- Empasiprubart IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesGeorgia
- Study dates
- 27 Jul 2026to 1 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia4 sites, 4 recruiting
- Recruiting
Pineo Medical Ecosystem
Tbilisi, K'alak'i T'bilisi, 114
Alexander Tsiskaridze, +1 857-350-4834, alexander.tsiskaridze@tsu.ge
- Recruiting
Aversi Clinic LTD
Tbilisi, 160
Gvantsa Giorgadze, MD, +995 599554483, Gvantsa.Giorgadze@aversi.ge
- Recruiting
Jo Ann Medical Center
Tbilisi
Miranda Demuria, MD, +995 598359525, mirandademuria@gmail.com
- Recruiting
S. Khechinashvili University Clinic, Ltd.
Tbilisi
Marina Janelidze, MD, marjaneli@yahoo.com
About this study
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
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.
Read more
The total study duration for each participant will be approximately 29 months.
More information can be found here: clinicaltrials.argenx.com/empasound
- Conditions
- Multifocal Motor Neuropathy (MMN)
- Being tested
- Empasiprubart IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empasiprubart IVBiological
Intravenous infusions of empasiprubart
| Study group | Role | What they receive |
|---|---|---|
| Empasiprubart IV | Experimental | Participants receive empasiprubart IV Receives: Biological: Empasiprubart IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 48 weeks
Secondary outcomes (9)
Change from baseline in GS in both hands over time
The grip strength (GS) will be measured using a vigorimeter
Measured: Up to 48 weeks
Change from baseline in MMN-RODS over time
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)
Measured: Up to 48 weeks
Change from baseline in mMRC-14 sum score over time
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
Measured: Up to 48 weeks
Percentage change from baseline in time to complete the 9-HPT with both hands over time
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).
Measured: Up to 48 weeks
Change from baseline in nerve CSA over time as measured by ultrasound imaging of the median nerve and brachial plexus
CSA : cross-sectional area
Measured: Up to 48 weeks
Serum concentrations of empasiprubart over time
Measured: Up to 60 weeks
Percentage change from baseline in free C2 and total C2 over time
C2 : complement component 2
Measured: Up to 60 weeks
Incidence of AEs and AESIs
AE : adverse event ; AESI : adverse event of special interest
Measured: Up to 60 weeks
Incidence of SAEs
SAE : Serious adverse event
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start27 Jul 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multifocal Motor Neuropathy (MMN)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610564
- Sponsor's protocol ID
- ARGX-117-8-MMN-1001
- Other IDs
- 2026-525171-20-00
- Acronym
- EmpaSound
- Status last verified
- Sep 2026
- First submitted
- 20 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07610564
- Acronym / sponsor ID
- EmpaSound / ARGX-117-8-MMN-1001
- Conditions
- Multifocal Motor Neuropathy (MMN)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empasiprubart IV | Experimental | Biological: Empasiprubart IVParticipants receive empasiprubart IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empasiprubart IVIntravenous infusions of empasiprubart | Biological | Empasiprubart IV |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Empasiprubart IV in people with Multifocal Motor Neuropathy (MMN), run by argenx at 4 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.