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Empasiprubart versus IVIg for treating CIDP in adults

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

Phase 3 Interventional argenx · NCT06920004

This trial tests whether empasiprubart works as well as IVIg and is safe for adults with CIDP who currently benefit from IVIg.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment218 (estimated)
Ages18 Years and up
SexAll
Sponsorargenx Industry-sponsored
Locations73 sites (Rancho Mirage, California and 72 other locations)
Trial IDNCT06920004 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial randomizes adults with CIDP who are on maintenance IVIg to receive either empasiprubart with an IVIg-matching placebo or IVIg with an empasiprubart-matching placebo for 24 weeks (Part A). After Part A, all participants enter an open-label extension (Part B) in which everyone receives empasiprubart for 96 weeks. Eligible participants must meet the 2021 EAN/PNS CIDP diagnostic criteria, have active disease with residual disability, and have responded to IVIg within the past five years. The trial compares clinical efficacy and safety during the blinded period and monitors longer-term outcomes during the open-label phase.

Who should consider this trial

Good fit: Adults with typical CIDP or specified CIDP variants who meet the 2021 EAN/PNS criteria, have active disease with residual disability, and have responded to IVIg within the past five years on a stable maintenance regimen are ideal candidates.

Not a fit: Patients with possible or purely sensory CIDP, other causes of polyneuropathy, coexisting autoimmune conditions that would confound assessment, or those on other long-acting immunomodulatory treatments are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, empasiprubart could become an effective alternative to IVIg and reduce reliance on plasma-derived therapy for some people with CIDP.

How similar studies have performed: Other immune-targeting therapies and alternative agents to IVIg have shown promise in CIDP in prior trials, but empasiprubart itself is still being tested in this phase 3 program.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Rancho Mirage, California and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Inflammatory Demyelinating PolyneuropathyCIDPCIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.