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NCT Number: NCT06742190

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multifocal Motor Neuropathy (MMN) MMN

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Melbourne Hospital, Parkville, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

empasiprubart

Biological

Intravenous infusion of empasiprubart

IVIG (Intravenous Immunoglobulin)

Biological

Intravenous infusion of IVIg

empasiprubart-placebo

Other

A placebo resembling the empasiprubart treatment

IVIg-placebo

Other

A placebo resembling the IVIg treatment

Primary outcomes

  1. Change from baseline in grip strength (4-week average) in the most affected hand at week 24

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Change from baseline in MMN-RODS centile score at week 24

    Time frame: Up to 24 weeks

    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

  2. Change from baseline in mMRC-14 sum score

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

    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.

  3. PGI-C actual value

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

    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.

  4. Change from baseline in CAP-PRI total score

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

    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.

  5. 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)

    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).

  6. Incidence of AEs, AESIs and SAEs

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

  7. Serum concentrations over time of empasiprubart

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

  8. 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)

  9. Incidence of anti-drug antibodies (ADA) against empasiprubart in serum

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

  10. Incidence of NAb against empasiprubart in serum

    Time frame: Up to 24 weeks (Part A), Up to 120 weeks (Part B)

  11. Change from baseline in grip strength (3-day moving average) of the least affected hand over time

    Time frame: Up to 24 weeks

  12. 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

  13. 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)

    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).

  14. 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)

    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.

  15. Proportion of participants and shift from baseline over time by level of severity on PGI-S

    Time frame: Up to 24 weeks

    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. 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)

  17. 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)

  18. 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)

  19. Changes from baseline in MMN-RODS centile score

    Time frame: Up to 120 weeks (part B)

    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

  20. Changes from baseline in grip strength (3-day moving average; both hands)

    Time frame: Up to 120 weeks (part B)

  21. Actual values of PGI-S over time

    Time frame: Up to 120 weeks (part B)

    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.

  22. Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24

    Time frame: Up to 24 weeks

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study 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

Acronym: Empassion

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Dec 19, 2024
Registry last updated
May 20, 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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