A Phase 2 interventional study of ARGX-117 and Placebo in Multifocal Motor Neuropathy (MMN), sponsored by argenx. Active, not recruiting at 27 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by argenx · Phase 2, Interventional, and Treatment
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.
argenx is the lead sponsor of 87 studies on the registry; 33 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP)
Biological: ARGX-117
Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP)
Biological: ARGX-117 · Other: Placebo
Intravenous administration of ARGX-117
Intravenous administration of placebo
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
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
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
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
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).
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)
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).
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
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.
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)
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).
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
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)
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
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.
Time frame: 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.
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
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.
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
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.
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
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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