Compares empasiprubart with IVIg in adults with chronic inflammatory demyelinating polyneuropathy
Tests empasiprubart against IVIg in adults with chronic inflammatory demyelinating polyneuropathy.
Plain-language title generated from the registry record
Registry title: A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Key facts
- Where
- Bologna, Milan, Pavia, Rome, Rozzano, and Verona, ItalySee the 8 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 12 November 2026.
Where in Italy
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- argenx
- Trial code
- NCT06920004EU 2024-520097-36-00
- Record updated
- 3 November 2026
- Original description
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
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
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
Inclusion: 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: 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.