Multifocal Motor Neuropathy (MMN)Phase 2ARDA+NCT05405361
A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
A Phase 2 study testing ARGX-117 in people with Multifocal Motor Neuropathy (MMN), run by argenx at 27 sites in 11 countries.
Trial summary
This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy… 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?
- ARGX-117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 27 sitesin 11 countries
- Study dates
- 18 Jan 2023to 30 Sep 2029
- Phase
- Phase 2
- 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
- Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
- Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117.
Who cannot join
- Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
- Clinical evidence of other significant serious diseases, have had a recent major surgery, 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.
- Currently participating in another interventional clinical study.
- Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.
Trial locations and contacts
27 sites in 11 countries.
27 sites in 11 countries
United States6 sites
Austin Neuromuscular Center
Austin, Texas, 78759
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
NorthShore University HealthSystem
Glenview, Illinois, 60026
University of Minnesota
Minneapolis, Minnesota, 55414
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
HonorHealth Neurology
Scottsdale, Arizona, 85251
France4 sites
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
Hôpital Roger Salengro (CHU de Lille)
Lille, 59037
CHU de Nice
Nice, 06001
Hôpital de la Pitié Salpétrière
Paris, 75651
Italy4 sites
IRCCS Ospedale San Raffaele S.r.l.
Milan, 20132
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Azienda Ospedaliera Sant' Andrea
Rome, 00189
IRCCS Humanitas Research Hospital
Rozzano, 20089
Spain3 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Germany2 sites
Universitätsklinikum Essen
Essen, 45147
Universitatsmedizin Gottingen (UMG) Georg-August-Universitaet
Göttingen, 37075
Poland2 sites
Michalski i Partnerzy Lekarze Spolka Partnerska
Krakow, 31-426
Warszawski Uniwersytet Medyczny
Warsaw, 02-097
United Kingdom2 sites
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Oxford University Hospitals NHS Trust
Oxford, OX3 9DU
Austria1 site
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090
About this study
Official title: A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.
- Conditions
- Multifocal Motor Neuropathy (MMN)
- 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 group | Role | What they receive |
|---|---|---|
| ARGX-117 | Experimental | Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP) Receives: Biological: ARGX-117 |
| Placebo | Experimental | Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP) Receives: Biological: ARGX-117; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes based on adverse event (AE) monitoring.
Measured: Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Secondary outcomes (19)
Change from baseline in the mMRC-10 sum score
The modified Medical Research Council (mMRC) sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs). The higher the score, the better the muscle strength
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants showing a deterioration of at least 2 points in mMRC-10 sum score
The modified Medical Research Council (mMRC) sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs). The higher the score, the better the muscle strength.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the mMRC-14 sum score
The modified Medical Research Council (mMRC) sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs). The higher the score, the better the muscle strength.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants showing a deterioration of at least 2 points in the mMRC-14 sum score
The modified Medical Research Council (mMRC) sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs). The higher the score, the better the muscle strength.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
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) sum score evaluates motor strength/weakness from predetermined muscle groups (upper and lower limbs). The higher the score, the better the muscle strength.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in GS
The grip strength (GS) will be measured by using a Martin-Vigorimeter. Each GS measurement will consist of 3 repeated contractions with the participant's maximal effort. The duration of each contraction will be 3 seconds. 3 repetitions will be executed consecutively by the right hand followed by 3 repetitions of the left hand. There will be a 30-second rest period between each of the 3 repetitions and a 2-minute rest period between each hand.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants with a decline of >30% in GS
The grip strength (GS) will be measured by using a Martin-Vigorimeter. Each GS measurement will consist of 3 repeated contractions with the participant's maximal effort. The duration of each contraction will be 3 seconds. 3 repetitions will be executed consecutively by the right hand followed by 3 repetitions of the left hand. There will be a 30-second rest period between each of the 3 repetitions and a 2-minute rest period between each hand.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the MMN-RODS
The Rasch-Built Overall Disability Scale for MMN (MMN-RODS) is a disease specific patient-reported outcome instrument constructed specifically to capture activity limitations in patients with MMN. The total score varies between 0 (worst outcome) and 50 (best outcome).
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the average time for the upper extremity (arm and hand) function (9-HPT, or timed pegboard test)
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: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants by level of severity on each dimension of the EQ-5D-5L
The Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores for each dimension include 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in EQ-5D-5L visual analog scale (VAS)
A vertical visual analog scale (VAS) is included in the EQ-5D-5L. Participants mark their health status from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the CAP-PRI
The Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI) includes the assessment of 15 items. The total score varies between 0 (best outcome) and 30 (worst outcome)
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the 9-item FSS
In the 9-item Fatigue Severity Scale (FSS) fatigue levels are rated from 1 to 7. A low value indicates that the statement is not very appropriate whereas a high value indicates agreement.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Values of the PGIC scale
The Patient Global Impression of Change (PGIC) is a 7-point scale depicting a participant's rating of overall improvement. The lower the score, the better the improvement.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants by level of severity of MMN as assessed by PGIS
The 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: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Values for work-related and household chore activities 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. These criteria form an important portion of work-related productivity and will be used to assess health-related and work-related productivity in the trial.
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Serum concentrations for ARGX-117
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in free C2, total C2, functional complement activity (CH50).
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Incidence of antidrug antibodies (ADA) against ARGX-117
Measured: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start18 Jan 2023
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405361
- Sponsor's protocol ID
- ARGX-117-2003
- Other IDs
- 2023-507052-69-00, 2023
- Acronym
- ARDA+
- Status last verified
- Mar 2026
- First submitted
- 17 May 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
- ClinicalTrials.gov ID
- NCT05405361
- Acronym / sponsor ID
- ARDA+ / ARGX-117-2003
- Conditions
- Multifocal Motor Neuropathy (MMN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 6 Jun 2022 (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.
This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARGX-117 | Experimental | Biological: ARGX-117Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP) |
| Placebo | Experimental | Biological: ARGX-117, Other: PlaceboParticipants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
- Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117.
Key exclusion criteria (4 listed)
- Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
- Clinical evidence of other significant serious diseases, have had a recent major surgery, 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.
- Currently participating in another interventional clinical study.
- Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.
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 |
|---|---|---|
| ARGX-117Intravenous administration of ARGX-117 | Biological | ARGX-117, Placebo |
| PlaceboIntravenous administration of placebo | Other | Placebo |
Primary outcome
Safety outcomes based on adverse event (AE) monitoring.
Time frame: Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
19 secondary outcomes
Change from baseline in the mMRC-10 sum score
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants showing a deterioration of at least 2 points in mMRC-10 sum score
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the mMRC-14 sum score
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants showing a deterioration of at least 2 points in the mMRC-14 sum score
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the average score of the 2 most important muscle groups as assessed by the mMRC-14 sum score
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in GS
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants with a decline of >30% in GS
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the MMN-RODS
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the average time for the upper extremity (arm and hand) function (9-HPT, or timed pegboard test)
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants by level of severity on each dimension of the EQ-5D-5L
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in EQ-5D-5L visual analog scale (VAS)
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the CAP-PRI
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in the 9-item FSS
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Values of the PGIC scale
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Proportion of participants by level of severity of MMN as assessed by PGIS
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Values for work-related and household chore activities of the HRPQ
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Serum concentrations for ARGX-117
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Change from baseline in free C2, total C2, functional complement activity (CH50).
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
Incidence of antidrug antibodies (ADA) against ARGX-117
Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
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 11 Mar 2026.
- 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.
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARGX-117 in people with Multifocal Motor Neuropathy (MMN), run by argenx at 27 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 2 inclusion and 4 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, France, Italy, Spain, Germany 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. 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?
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?
Safety outcomes based on adverse event (AE) monitoring. (time frame: Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first). 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 11 Mar 2026.