Multifocal Motor Neuropathy (MMN)Phase 3EmpassionNCT06742190
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
A Phase 3 study testing Empasiprubart and IVIG (Intravenous Immunoglobulin) in people with Multifocal Motor Neuropathy (MMN) and MMN, run by argenx at 109 sites in 26 countries.
Trial summary
The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multifocal Motor Neuropathy (MMN), MMN
- What is being tested?
- Empasiprubart and IVIG (Intravenous Immunoglobulin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 109 sitesin 26 countries
- Study dates
- 18 Dec 2024to Dec 2029
- Phase
- Phase 3
- 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 of age and the local legal age of consent for clinical studies
- Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
- Has responded to IVIg in the past 5 years.
- Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle
- Is receiving a maintenance regimen (no change in frequency, and no change in dose >10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
- Minimum converted weekly IVIg dose of ≥0.125 g/kg
- Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration
Who cannot join
- Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk
- Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
Trial locations and contacts
109 sites in 26 countries.
109 sites in 26 countries
United States24 sites
Dent Neurologic Institute Amherst
Amherst, New York, 14226
University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic)
Aurora, Colorado, 80045
National Neuromuscular Research Institute
Austin, Texas, 78759-8402
EZR Research LLC
Boca Raton, Florida, 33486
Northwestern University
Chicago, Illinois, 60611
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Perelman Center for Advanced Medicine
Columbia, Maryland, 21044
UC Irvine - MDA ALS and Neuromuscular Center
Columbia, Maryland, 21044
Healthcare Innovations Institute, LLC
Coral Springs, Florida, 33067
University of Kansas Medical Center
Fairway, Kansas, 66205
NeuroCarePlus
Houston, Texas, 77094
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
University of Miami Miller School of Medicine
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55414
University of North Carolina at Chapel Hill
Morrisville, North Carolina, 27560
Yale University School of Medicine
New Haven, Connecticut, 06511
Columbia University Medical Center
New York, New York, 10032
The Neurology Group
Pomona, California, 91767
Oregon Health and Science University
Portland, Oregon, 97239
Samir Macwan, M.D., Inc.
Rancho Mirage, California, 92270
University of California San Francisco
San Francisco, California, 94143
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, 85251
University of South Florida
Tampa, Florida, 33612
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
France11 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
CHU de Brest - Hôpital La Cavale Blanche
Brest, 29609
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, 69500
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Roger Salengro
Lille, 59000
CHU Limoges - Dupuytren 1
Limoges, 87042
AP-HM- Hôpital de La Timone
Marseille, 13005
AP-HM- Hôpital de La Timone
Marseille, 13385
CHU de Nice-Hôpital Pasteur
Nice, 6001
AP-HP - Hôpital de la Pitié Salpétrière
Paris, 75013
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200
Italy9 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Ospedale Policlinico San Martino IRCCS
Genova, 16132
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
Gussago, 25064
Az. Ospedaliera Universitaria Policlinico G. Martino
Messina, 98124
Ospedale San Raffaele S.r.l.
Milan, 20132
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Milan, 20133
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, 00189
Fondazione PTV Policlinico Tor Vergata
Roma, 133
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Spain9 sites
Hospital General Universitario Dr. Balmis
Alicante, 03010
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Clinico San Carlos
Madrid, 28039
Hospital Universitario de Basurto
Madrid, 48013
Hospital Quironsalud Malaga
Málaga, 29004
Hospital Universitario de Donostia
San Sebastián, 8035
Japan7 sites
Juntendo University Hospital
Bunkyō City, 113-8431
Institute of Science Tokyo Hospital
Bunkyō City, 113-8519
Chiba University Hospital
Chūōku, 260-8677
National Center of Neurology and Psychiatry
Kodaira, 187-8502
Nagoya University Hospital
Nagoya, 4668560
Teikyo University Hospital
tabashi City, 173-8606
Yamaguchi University Hospital
Ube, 755-0067
Germany6 sites
Universitätsklinikum Essen
Essen, 45147
Universität Georg August
Göttingen, 37075
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23538
Universitätsklinikum Münster
Münster, 48149
Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH
Potsdam, 14471
Universitätsklinikum Würzburg
Würzburg, 97080
Poland5 sites
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
Centrum Medyczne Neurologia Slaska
Katowice, 40-689
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Galen Clinic -- Lublin
Lublin, 20--64
UCK WUM, Centralny Szpital Kliniczny
Warsaw, 02-097
United Kingdom5 sites
Queen Elizabeth University Hospital
Glasgow, G51 4TF
John Radcliffe Hospital
Oxford, OX3 7LE
Salford Royal Hospital
Salford, M6 8HD
Royal Hallamshire Hospital
Sheffield, S10 2JF
Musgrove Park Hospital
Taunton, TA1 5DA
Australia4 sites
Royal Melbourne Hospital
Parkville, 3050
Gold Coast University Hospital
Southport, 4215
Brain and Mind Center
Sydney, 2609
Princess Alexandra Hospital
Woolloongabba, 4102
Brazil4 sites
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, 14051
Sociedade de Ensino Superior Estacio de Sa Ltda
Rio de Janeiro, 22620-172
Escola Bahiana de Medicina e Saude Publica
Salvador, 40290-000
PSEG Centro de Pesquisa Clínica
São Paulo, 04038-002
Belgium3 sites
UZ Antwerpen
Edegem, 2650
UZ Leuven
Leuven, 3000
Hôpital de la Citadelle
Liège, 4000
Canada3 sites
Neuro-Outaouais Clinic
Gatineau, J8Y 1W2
London Health Sciences Centre
London, N6A 5A5
St. Paul's Neurology Associates
Vancouver, V6Z 2H2
Czechia3 sites
Fakultni nemocnice Brno
Brno, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Vseobecna Fakultni Nemocnice V Praze
Prague, 128 08
Denmark2 sites
Aarhus Universitetshospital
Aarhus, 8200
Rigshospitalet-Inge Lehmanns Vej 8
Copenhagen, 2100
Greece2 sites
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, 124 62
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
Slovakia2 sites
Univerzitna nemocnica Bratislava
Bratislava, 821 01
Univerzitna nemocnica MARTIN
Martin, 036 59
Lithuania1 site
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161
Portugal1 site
ULS de Santo António, EPE - Hospital de Santo António
Porto, 4099-001
About this study
Official title: A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.
More information can be found here: https://clinicaltrials.argenx.com/empassion
- Conditions
- Multifocal Motor Neuropathy (MMN), MMN
- Being tested
- Empasiprubart, IVIG (Intravenous Immunoglobulin), Empasiprubart-placebo, IVIg-placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpasiprubartBiological
Intravenous infusion of empasiprubart
IVIG (Intravenous Immunoglobulin)Biological
Intravenous infusion of IVIg
Empasiprubart-placeboOther
A placebo resembling the empasiprubart treatment
IVIg-placeboOther
A placebo resembling the IVIg treatment
| Study group | Role | What they receive |
|---|---|---|
| Part A - empasiprubart + IVIg-placebo | Experimental | During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm Receives: Biological: Empasiprubart; Other: IVIg-placebo |
| Part A - IVIg + empasiprubart-placebo | Active comparator | During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm Receives: Biological: IVIG (Intravenous Immunoglobulin); Other: Empasiprubart-placebo |
| Part B - empasiprubart | Experimental | After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg) Receives: Biological: Empasiprubart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in grip strength (4-week average) in the most affected hand at week 24
Measured: Up to 24 weeks
Secondary outcomes (22)
Change from baseline in MMN-RODS centile score at week 24
The 25-Item Rasch-Built Overall Disability Scale for MMN (MMN-RODS) is a questionnaire about the relationship between daily activities and the participants' health
Measured: Up to 24 weeks
Change from baseline in mMRC-14 sum score
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 24 weeks (Part A), Up to 120 weeks (Part B)
PGI-C actual value
The Patient Global Impression of Change (PGI-C) is a 7-point scale depicting a participant's rating of overall improvement. The lower the score, the better the improvement.
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in CAP-PRI total score
The Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) includes the assessment of 15 items. Items will be scored 0 (not at all), 1 (a little bit), or 2 (a lot), yielding a total score that ranges from 0 to 30.
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Percentage change from baseline in time to complete the 9-HPT with the dominant hand
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 24 weeks (Part A), Up to 120 weeks (Part B)
Incidence of AEs, AESIs and SAEs
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Serum concentrations over time of empasiprubart
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Percent changes from baseline in free C2 and total C2 over time
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Incidence of anti-drug antibodies (ADA) against empasiprubart in serum
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Incidence of NAb against empasiprubart in serum
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in grip strength (3-day moving average) of the least affected hand over time
Measured: Up to 24 weeks
AUC of change from baseline in grip strength (3-day moving average) for the most and least affected hands
Measured: Up to 24 weeks
Percentage change from baseline in time to complete the 9-HPT with the nondominant hand 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 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in sum scores for mMRC-10 and mMRC-14 restricted to the 2 most affected muscle groups over time
The modified Medical Research Council (mMRC) 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 24 weeks (Part A), Up to 120 weeks (Part B)
Proportion of participants and shift from baseline over time by level of severity on PGI-S
Patient Global Impression of Severity (PGIS) is a 7-point scale depicting a participant's rating of overall illness severity. Higher scores mean a higher severity.
Measured: Up to 24 weeks
Change from baseline in Rasch-Transformed Fatigue Severity Scale (RT-FSS) score over time
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in physical component and mental component scores of 12-Item Short Form Survey (SF-12) over time
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Proportion of participants and shift from baseline by each dimension of the EQ-5D-5L scale
Measured: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Changes from baseline in MMN-RODS centile score
The 25-Item Rasch-Built Overall Disability Scale for MMN (MMN-RODS) is a questionnaire about the relationship between daily activities and the participants' health
Measured: Up to 120 weeks (part B)
Changes from baseline in grip strength (3-day moving average; both hands)
Measured: Up to 120 weeks (part B)
Actual values of PGI-S over time
Patient Global Impression of Severity (PGIS) is a 7-point scale depicting a participant's rating of overall illness severity. Higher scores mean a higher severity.
Measured: Up to 120 weeks (part B)
Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start18 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2029 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742190
- Sponsor's protocol ID
- ARGX-117-2302
- Other IDs
- 2024-516473-72-00
- Acronym
- Empassion
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 22 Sep 2026
- Results posted
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
- ClinicalTrials.gov ID
- NCT06742190
- Acronym / sponsor ID
- Empassion / ARGX-117-2302
- Conditions
- Multifocal Motor Neuropathy (MMN), MMN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Dec 2024 (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 this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.
More information can be found here: https://clinicaltrials.argenx.com/empassion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A - empasiprubart + IVIg-placebo | Experimental | Biological: Empasiprubart, Other: IVIg-placeboDuring the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm |
| Part A - IVIg + empasiprubart-placebo | Active comparator | Biological: IVIG (Intravenous Immunoglobulin), Other: Empasiprubart-placeboDuring the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm |
| Part B - empasiprubart | Experimental | Biological: EmpasiprubartAfter completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is at least 18 years of age and the local legal age of consent for clinical studies
- Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
- Has responded to IVIg in the past 5 years.
- Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle
- Is receiving a maintenance regimen (no change in frequency, and no change in dose >10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
Key exclusion criteria (2 listed)
- Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk
- Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
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 |
|---|---|---|
| EmpasiprubartIntravenous infusion of empasiprubart | Biological | Part A - empasiprubart + IVIg-placebo, Part B - empasiprubart |
| IVIG (Intravenous Immunoglobulin)Intravenous infusion of IVIg | Biological | Part A - IVIg + empasiprubart-placebo |
| Empasiprubart-placeboA placebo resembling the empasiprubart treatment | Other | Part A - IVIg + empasiprubart-placebo |
| IVIg-placeboA placebo resembling the IVIg treatment | Other | Part A - empasiprubart + IVIg-placebo |
Primary outcome
Change from baseline in grip strength (4-week average) in the most affected hand at week 24
Time frame: Up to 24 weeks
22 secondary outcomes
Change from baseline in MMN-RODS centile score at week 24
Time frame: Up to 24 weeks
Change from baseline in mMRC-14 sum score
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
PGI-C actual value
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in CAP-PRI total score
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Percentage change from baseline in time to complete the 9-HPT with the dominant hand
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Incidence of AEs, AESIs and SAEs
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Serum concentrations over time of empasiprubart
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Percent changes from baseline in free C2 and total C2 over time
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Incidence of anti-drug antibodies (ADA) against empasiprubart in serum
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Incidence of NAb against empasiprubart in serum
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in grip strength (3-day moving average) of the least affected hand over time
Time frame: Up to 24 weeks
AUC of change from baseline in grip strength (3-day moving average) for the most and least affected hands
Time frame: Up to 24 weeks
Percentage change from baseline in time to complete the 9-HPT with the nondominant hand over time
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in sum scores for mMRC-10 and mMRC-14 restricted to the 2 most affected muscle groups over time
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Proportion of participants and shift from baseline over time by level of severity on PGI-S
Time frame: Up to 24 weeks
Change from baseline in Rasch-Transformed Fatigue Severity Scale (RT-FSS) score over time
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Change from baseline in physical component and mental component scores of 12-Item Short Form Survey (SF-12) over time
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Proportion of participants and shift from baseline by each dimension of the EQ-5D-5L scale
Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)
Changes from baseline in MMN-RODS centile score
Time frame: Up to 120 weeks (part B)
Changes from baseline in grip strength (3-day moving average; both hands)
Time frame: Up to 120 weeks (part B)
Actual values of PGI-S over time
Time frame: Up to 120 weeks (part B)
Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24
Time frame: Up to 24 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 22 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
109 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empasiprubart and IVIG (Intravenous Immunoglobulin) in people with Multifocal Motor Neuropathy (MMN) and MMN, run by argenx at 109 sites in 26 countries.
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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 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 109 sites in United States, France, Italy, Spain, Japan and 21 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in grip strength (4-week average) in the most affected hand at week 24 (time frame: Up to 24 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 22 Sep 2026.