Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06920004

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).

More information can be found here: https://clinicaltrials.argenx.com/emvigorate

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy Autoimmune Diseases Autoimmune Diseases of the Nervous System CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INECO Neurociencias Oroño, Rosario, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
  • Has responded to IVIg in the past 5 years
  • Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
  • Has residual disability and active disease

Exclusion criteria

  • Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
  • Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Use of other long-acting immunomodulatory treatment

Treatment and study plan

empasiprubart

Biological

Intravenous infusion of empasiprubart

IVIG

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. Reduction of ≥1 point compared with baseline in aINCAT score at week 24

    Time frame: up to 24 weeks

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Secondary outcomes

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

    Time frame: up to 24 weeks

    Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).

  2. Change from baseline in MRC-SS at week 24

    Time frame: up to 24 weeks

    The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).

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

    Time frame: up to 24 weeks

    The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.

  4. Time to reduction of ≥1 point from baseline in aINCAT score

    Time frame: up to 24 weeks

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  5. Change from baseline in TUG at week 24

    Time frame: up to 24 weeks

    The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.

  6. Time to increase of ≥1 point compared with baseline in aINCAT score

    Time frame: Up to 24 weeks

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  7. Change from baseline in grip strength (3-day moving average) of both hands over time

    Time frame: up to 24 weeks + 96 weeks (Part B)

    The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.

  8. Change from baseline in grip strength (daily average) for both hands

    Time frame: up to 24 weeks + 96 weeks (Part B)

    The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand.

  9. Change from baseline in MRC-SS over time

    Time frame: up to 96 weeks (Part B)

    The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).

  10. Change from baseline in aINCAT over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

  11. Change from baseline in EQ-5D-5L over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).

  12. Change from baseline in RT-FSS over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.

  13. Change from baseline in SF-12 over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.

  14. Change from baseline in BPI-SF over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference.

  15. PGI-S values over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness.

  16. PGI-C values over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

    The Patient Global Impression of Change (PGI-C) is a patient- reported outcome measure that reflects the patient's belief about the efficacy of treatment.

  17. Values for work-related and household chore activities of the HRPQ

    Time frame: up to 24 weeks

    The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.

  18. Percentage of scheduled hours lost in total (absenteeism+ presenteeism)

    Time frame: up to 24 weeks

  19. Change from baseline in I-RODS centile points score over time

    Time frame: Up to 96 weeks (Part B)

    Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).

  20. Change from baseline in TUG over time

    Time frame: Up to 96 weeks (Part B)

    The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.

  21. Incidence of antidrug antibodies against empasiprubart in serum

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

  22. Incidence of neutralizing antibodies against empasiprubart in serum

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

  23. Incidence of (serious) adverse events

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

  24. Percentage change from baseline in free C2 and total C2 over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

  25. Serum concentrations of empasiprubart over time

    Time frame: up to 24 weeks (Part A) + 96 weeks (Part B)

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

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 Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Acronym: emvigorate

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Apr 9, 2025
Registry last updated
Jul 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.