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NCT Number: 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

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.

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Key information

Conditions

Multifocal Motor Neuropathy (MMN)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medizinische Universitat Wien (Medical University of Vienna), Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ARGX-117

Biological

Intravenous administration of ARGX-117

Placebo

Other

Intravenous administration of placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. Change from baseline in GS

    Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

    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.

  7. 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

    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.

  8. 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

    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).

  9. 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

    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).

  10. 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

    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.

  11. 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

    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).

  12. 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

    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)

  13. 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

    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.

  14. Values of the PGIC scale

    Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

    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.

  15. 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

    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.

  16. 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

    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.

  17. Serum concentrations for ARGX-117

    Time frame: Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study 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

Acronym: ARDA+

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jun 6, 2022
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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