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Taking people in SloveniaPhase 3

Compares empasiprubart with IVIg in adults with chronic inflammatory demyelinating polyneuropathy

Tests empasiprubart against IVIg in adults with chronic inflammatory demyelinating polyneuropathy.

Key facts

Who runs it
argenx
Where
Ljubljana and Maribor, SloveniaSee the 2 sitesAlso in 32 other countries, 111 sites
Registry title
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Status
Recruiting
Phase
Phase 3
People taking part
218 people, planned
Started
22 Aug 2025
Expected to end
Sept 2030
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • empasiprubart
  • IVIg
  • empasiprubart-placebo
  • IVIg-placebo
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with CIDP (chronic inflammatory demyelinating polyneuropathy) who have responded to IVIg and still have active disease. It compares empasiprubart with IVIg.

Age
18 years or older
Sex
All sexes can join
Disease stage
Typical CIDP, or one of these variants: motor CIDP, multifocal CIDP (Lewis-Sumner syndrome), focal CIDP or distal CIDP. Residual disability and active disease.
Earlier treatment
Responded to IVIg in the past 5 years. Currently on IVIg maintenance treatment with a weekly dose of at least 0.125 g/kg.

Main reasons for not taking part

  • Another autoimmune disease or medical condition that could interfere with judging CIDP symptoms or put the person at undue risk, including polyneuropathy of other causes
  • Possible CIDP or sensory CIDP under the EAN/PNS 2021 guidelines
  • Use of other long-acting immunomodulatory treatment

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Slovenia

Also in 32 other countries, 111 sites

  • University Medical Center LjubljanaLjubljana, SloveniaTaking people
  • Univerzitetni klinični center MariborMaribor, SloveniaTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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

The 3 groups in the trial

  • Part A - empasiprubart + IVIg-placeboTreatment being tested

    During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.

    Treatment: empasiprubart and IVIg-placebo

  • Part A - IVIg + empasiprubart-placeboExisting treatment, for comparison

    During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.

    Treatment: IVIg and empasiprubart-placebo

  • Part B - empasiprubartTreatment being tested

    After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.

    Treatment: empasiprubart and empasiprubart-placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Compares empasiprubart with IVIg in adults with chronic inflammatory demyelinating polyneuropathyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026