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Taking people in BulgariaPhase 3

Tests empasiprubart against placebo in adults with CIDP

Tests empasiprubart, or a placebo, in adults with chronic inflammatory demyelinating polyneuropathy.

Key facts

Who runs it
argenx
Where
Pleven, Sofia, and Sofiya, BulgariaSee the 5 sitesAlso in 26 other countries, 98 sites
Registry title
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Status
Recruiting
Phase
Phase 3
People taking part
160 people, planned
Started
16 Sept 2025
Expected to end
23 Jan 2031
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Empasiprubart IV
  • Placebo IV
Record updated
9 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 chronic inflammatory demyelinating polyneuropathy (CIDP) who still have disability and active disease.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Typical CIDP, or motor, multifocal, focal or distal CIDP, meeting the 2021 EAN/PNS guideline criteria, with residual disability and active disease.
Earlier treatment
People can be new to CIDP treatment, can have stopped treatment, or can be on treatment now. Those on treatment must stop it before the first study dose and be willing to switch to the study drug.

Main reasons for not taking part

  • Only possible CIDP under the 2021 EAN/PNS guidelines
  • Sensory CIDP, including sensory-predominant CIDP
  • Polyneuropathy of other causes
  • Clinical diagnosis of systemic lupus erythematosus (SLE)
  • Other long-acting immunomodulatory treatment, or past total lymphoid irradiation or bone marrow transplantation

The registry criteria, word for word

Show all 10 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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
  • Has residual disability and active disease
  • Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
  • Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP

Who cannot take part

  • Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
  • Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Sensory CIDP (including sensory-predominant CIDP)
  • Polyneuropathy of other causes
  • Clinical diagnosis of systemic lupus erythematosus (SLE)

Where in Bulgaria

Also in 26 other countries, 98 sites

  • University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EADPleven, BulgariaTaking people
  • Alexandrovska University HospitalSofia, BulgariaTaking people
  • Medical Center Medica 2005 EOODSofia, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EADSofia, BulgariaTaking people
  • University Multiprofile Hospital For Active Treatment And Emergency Medicine N I PirogovSofiya, BulgariaTaking people

About the trial

What the trial wants to find out

The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo 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/emnergize

The 3 groups in the trial

  • Part A - EmpasiprubartTreatment being tested

    Participants receive empasiprubart during part A

    Treatment: Empasiprubart IV

  • Part A - PlaceboPlacebo, for comparison

    Participants receive placebo during part A

    Treatment: Placebo IV

  • Part B - EmpasiprubartTreatment being tested

    Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.

    Treatment: Empasiprubart IV

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, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Plain-language title
Tests empasiprubart against placebo in adults with CIDPGenerated 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
9 November 2026