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Multifocal Motor NeuropathyPhase 2ARDANCT05225675

A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy

A Phase 2 study testing ARGX-117 in people with Multifocal Motor Neuropathy, run by argenx at 40 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multifocal Motor Neuropathy
What is being tested?
ARGX-117
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
40 sitesin 11 countries
Study dates
31 Mar 2022to 4 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Capable of giving signed informed consent form (ICF)
  • Male/female at least 18 years of age at the time the informed consent form (ICF) is signed
  • Probable or definite MMN according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) (EFNS/PNS) 2010 guidelines at screening confirmed by the MMN Confirmation Committee (MCC)
  • Receiving a stable IVIg regimen for at least 3 months before screening or recently initiated IVIg treatment
  • IVIg treatment dependency confirmation by the MMN Confirmation Committee (MCC)
  • Immunization with the first meningococcal vaccine and pneumococcal vaccine, and the single Haemophilus influenza type B vaccine must be performed at least 14 days before IMP administration at V1 according to local country-specific immunization schedules. A documented history of vaccination against Neisseria meningitides, Haemophilus influenza type B, and streptococcus pneumonia will be permitted
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Who cannot join

  • Any coexisting condition which may interfere with the outcome assessments
  • Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease or other inflammatory neuropathies
  • Severe psychiatric disorder, history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the participant or could affect adherence with the trial protocol.
  • Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVIg monitoring period (IVMP).
  • Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of MMN or put the participant at undue risk (eg, SLE).
  • History of malignancy unless resolved by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following carcinomas will be eligible:
Show all 23Show fewer
  • Adequately treated basal cell or squamous cell skin cancer
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histological finding of prostate cancer
  • Clinical evidence of other significant serious diseases, have had a recent major surgery (including a splenectomy at any time), or who have any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk
  • Prior/concomitant therapy
  • Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening
  • Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP.
  • Positive serum test at screening for an active viral infection with any of the following conditions:
  • Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
  • Hepatitis C virus (HCV) based on HCV antibody assay
  • HIV based on test results that are associated with an AIDS-defining condition
  • Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
  • Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients
  • Female participants with a positive serum or urine pregnancy test, lactating females, and those who intend to become pregnant during the trial or within 15 months after last dose of the IMP
  • ALT or AST ≥2 × upper limit of normal and total bilirubin ≥1.5 × upper limit of normal of the central laboratory reference range
  • An estimated glomerular filtration rate of ≤60 mL/min/1.73m2

Trial locations and contacts

40 sites in 11 countries.

40 sites in 11 countries

United States13 sites

  • Austin Neuromuscular Center

    Austin, Texas, 78756

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • NorthShore University HealthSystem

    Glenview, Illinois, 60026

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • HonorHealth Research Institute-Neuroscience Research

    Maitland, Florida, 32751

  • University of Minnesota Delware Clinic Research Unit

    Minneapolis, Minnesota, 55414

  • West Virginia University Medicine

    Morgantown, West Virginia, 26506

  • Perelman Center for Advanced Medicine-University of Penssylvania

    Philadelphia, Pennsylvania, 19104

  • California Pacific Medical Center-Forbes Norris MDA/ALS Research Center

    San Francisco, California, 94109

  • HonorHealth Research Institute-Neuroscience Research

    Scottsdate, Arizona, 85251

  • University of South Florida Carol and Frank Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

Germany5 sites

  • Katholisches Klinikum Bochum

    Bochum, 44791

  • Universitatsklinikum Essen

    Essen, 45147

  • Universitatsmedzin Gottingen, Klinik fur Neurologie

    Göttingen, 37075

  • Medizinische Hochschule Hannover Klinik Fur Neurologie

    Hanover, 30625

  • Universitatsklinikum Munster

    Münster, 48419

Other trials in Germany

France4 sites

  • CHU de Bordeaux-Hopital Pellegrin

    Bordeaux, 33076

  • CHRU de Lille-Hopital Roger Salengro

    Lille, 59037

  • CHU de Nice-Hopital Pasteur 2

    Nice, 06001

  • Hopital Pitie Salpetriere

    Paris, 75651

Other trials in France

Italy4 sites

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Univeritaria Pisana-UOS Neurologia

    Pisa, 56126

  • Azienda Ospedaliera Sant'Andrea-UOS Malattie Neuromuscolari

    Rome, 00189

  • Instituto Clinico Humanitas (IRCCS)

    Rozzano, 20089

Other trials in Italy

Spain3 sites

  • Hospital Universitario Vall d'Herbon

    Barcelona, 08035

  • Hospital de la Santa Creu I Santa Pau -Sevicio Neurologia

    Barcelona, 08041

  • Hospital Universitari I Politecnic La Fe de Valencia-Servicio Neurologia

    Valencia, 46026

Other trials in Spain

United Kingdom3 sites

  • Queen Elisabeth University Hospital

    Glasgow, G51 4TF

  • University College London Hospital

    London, ZC1N 3BG

  • Oxford University Hospitals NHS Trust-Jonh Radcliffe Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

Canada2 sites

  • Genge Partners Montreal

    Québec, H4A 3TA

  • Toronto General Hospital

    Toronto, M5G 2C4

Other trials in Canada

Netherlands2 sites

  • Amsterdam UMC location AMC, Dep of Neurology

    Amsterdam, 1105 AZ

  • University Medical Centre Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Poland2 sites

  • Michalscy I Partnerzy Lekarze Spolka Partnerska

    Krakow, 31-426

  • Uniwersyteckie centrum kliniczne Warszawskiego

    Warsaw, 02-097

Other trials in Poland

Austria1 site

  • Medizinische Universitat Wien Universitatsklienik fur Neurologie

    Vienna, 1090

Other trials in Austria

Belgium1 site

  • AZ Sint-Lucas

    Ghent, 9000

Other trials in Belgium

About this study

Official title: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy

This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).

Being tested
ARGX-117, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARGX-117Biological

    Intravenous administration of ARGX-117

  • PlaceboOther

    Intravenous administration of placebo

Study groups in NCT05225675
Study groupRoleWhat they receive
ARGX-117ExperimentalIntravenous administration of ARGX-117
Receives: Biological: ARGX-117
PlaceboPlacebo comparatorIntravenous administration of placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With AEs and SAEs

    AE : Adverse Events, SAE: Serious Adverse Events

    Measured: Up to 80 weeks

Secondary outcomes (20)

  1. Time to the First Retreatment With IVIg

    The time to first retreatment with intravenous immunoglobulin (IVIg) is defined as the time from the last IVIg administration before randomization until the first IVIg retreatment during the 16-week treatment period

    Measured: Up to 16 weeks

  2. Time-to-relapse

    Time-to-relapse is defined as the time from randomization until a participant met the threshold for clinically meaningful deterioration

    Measured: Up to 16 weeks

  3. iAUC of the Change From Baseline in mMRC-10 Sum Score

    The Modified Medical Research Council (mMRC)-10 sum score assesses muscle strength of 10 muscles groups, both sides (left and right). A score between 0 (paralysis) and 5 (normal strength) is assigned for each muscle group. A higher value indicates better muscle strength. The total score, ranging from 0 to 100, is based on the sum of both the left and right side of the body. The Incremental Area Under Curve (iAUC) is the area under the curve of the change from baseline in the Modified Medical Research Council (mMRC)-10 score. A positive AUC indicates a favorable outcome while a negative AUC indicates an unfavorable outcome.

    Measured: Up to 16 weeks

  4. Change From Baseline in the Average Score of the 2 Most Important Muscle Groups as Assessed by the mMRC-14 Sum Score

    The Modified Medical Research Council (mMRC)-14 assesses muscle strength of 14 muscles groups, both sides (left and right). A score between 0 and 5 (normal strength) is assigned. This endpoint is the change from baseline in the average score of the 2 most important muscle groups affected by the disease. It ranges between 0 and 5. A change of more than 0 represents an improvement in strength, and a change less than 0 represents worsening.

    Measured: At week 16

  5. Change From Baseline in the mMRC-14 Sum Score

    The Modified Medical Research Council (mMRC)-14 scores range from 0 to 140 with a higher score representing better muscle strength. A change of more than 0 represents an improvement in strength, and a change less than 0 represents worsening.

    Measured: At week 16

  6. Proportion of Participants Showing a Deterioration of at Least 2 Points as Assessed by the mMRC-10 Sum Score

    The Modified Medical Research Council (mMRC)-10 scores evaluates motor strength/weakness from 10 predetermined muscle groups. A higher proportion of participants showing a deterioration represents a worsening of the outcome.

    Measured: Up to 16 weeks

  7. iAUC of the Change From Baseline in GS Daily Average

    Measurement of grip strength (GS) has been done using the Martin vigorimeter in kPa. The incremental Area Under Curve (iAUC) is the area under the curve of the change from baseline of GS daily average. The 3 daily measurements of GS from the left hand and the 3 daily measurements of GS from the right hand have been recorded and the daily average for the left hand and right hand has been calculated, respectively.

    Measured: Up to 16 weeks

  8. Percent Change From Baseline in GS 3-day Moving Average

    Measurement of grip strength (GS) has been done using the Martin vigorimeter in kPa.

    The 3 daily measurements of GS from the left hand and the 3 daily measurements of GS from the right hand have been recorded and the daily average for the left hand and right hand has been calculated, respectively. A 3-day moving average has been generated based on the average over the last 3 days of the obtained daily averages for each hand.

    Measured: At week 16

  9. Change From Baseline in the MMN-RODS Centile Score

    The Rasch-built Overall Disability Scale for MMN (MMN-RODS) is a disease-specific PRO instrument constructed to capture activity limitations in patients with MMN. Raw sum scores of the 25-item MMN-RODS (range, 0-50) were converted to a centile metric score ranging from 0 to 100. Lower scores indicated a greater degree of disability.

    Measured: At week 16

  10. Percent Change From Baseline in the Average Time for Upper Extremity (Arm and Hand) Function

    The 9-Hole Peg Test (9-HPT) results are based on the time to complete the assessment with a shorter time representing better muscle strength. A change of less than 0 represents an improvement in strength, and a change more than 0 represents worsening.

    Measured: At week 16

  11. Proportion of Participants by Level of Severity on Each Dimension of the EQ-5D-5L Scale

    The EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale includes five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is ranked with a level 1-5 with level 1 being no problems and level 5 representing extreme problems.

    Measured: At week 16

  12. Change From Baseline in Quality of Life Using EQ-5D-5L Visual Analog Scale

    The EQ-5D-5L visual analog scale is from 0-100 with 0 representing the worst health. A change of more than 0 represents an improvement in health, and a change of less than 0 represents worsening.

    Measured: At week 16

  13. Change From Baseline in the CAP-PRI

    The Chronic Acquired Polyneuropathy Patient-reported Index (CAP-PRI) assesses disease-specific quality of life. This instrument includes the assessment of 15 items yielding a total score ranging from 0 to 30. A change of less than 0 represents an improvement in health, and a change more than 0 represents worsening.

    Measured: At week 16

  14. Proportion of Participants by Level of Improvement Using the PGI-C Scale

    Patient Global Impression of Change (PGI-C) scale ranks a patients condition from 1-7 with 1 representing the most improvement and 7 representing the most decline in their condition.

    Measured: Up to 16 weeks

  15. Change From Baseline in the 9-item FSS Average Total Score

    9-item Fatigue Severity Scale (FSS) average score is the sum of the 9 items divided by the number of items. It ranges from 0 to 7 a higher score representing more severe fatigue. A change of less than 0 indicates an improvement.

    Measured: Up to 16 weeks

  16. Percent of Total Hours for Work-related and Household Chore Activities Lost, as Part of the HRPQ

    The Health-Related Productivity Questionnaire (HRPQ) provides data related to missed hours at work or educational activities and reduced effectiveness during any attempted work.

    Measured: Up to 16 weeks

  17. Change From Baseline in Effectiveness, Side Effects, Convenience, and Overall Satisfaction Scores as Assessed by the TSQM-14

    Each Treatment Satisfaction Questionnaire for Medication-14 items (TSQM-14) domain score ranges from 0-100 with higher scores representing greater satisfaction with the treatment. A change greater than 0 indicates an improvement in satisfaction.

    Measured: Up to 16 weeks

  18. Maximum Empasiprubart Serum Concentrations (Cmax)

    Measured: Up to 16 weeks

  19. Percent Change From Baseline in Free C2, Total C2, and Functional Complement Activity (CH50)

    Measured: At week 16

  20. Incidence of Antidrug Antibodies (ADA) Against Empasiprubart

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start31 Mar 2022
  3. Primary completion4 Jun 2024
  4. Study completion4 Jun 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05225675
Sponsor's protocol ID
ARGX-117-2002
Acronym
ARDA
Status last verified
Apr 2026
First submitted
5 Nov 2021
Last updated
8 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARGX-117 in people with Multifocal Motor Neuropathy, run by argenx at 40 sites in 11 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 23 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Germany, France, Italy, Spain and 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With AEs and SAEs (time frame: Up to 80 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05225675.

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 8 May 2026.

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