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Chronic Inflammatory Demyelinating PolyneuropathyBiologicalPhase 3

What this study is

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

What's being tested

  • empasiprubart

    Intervention · BIOLOGICAL

    Intravenous infusion of empasiprubart

  • IVIg

    Intervention · BIOLOGICAL

    Intravenous infusion of IVIg

  • empasiprubart-placebo

    Intervention · OTHER

    A placebo resembling the empasiprubart treatment

  • IVIg-placebo

    Intervention · OTHER

    A placebo resembling the IVIg treatment

Study details

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
Sponsor
argenx
Conditions
Chronic Inflammatory Demyelinating Polyneuropathy · CIDP · CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Enrolling
218 people
Starts
2025-08-22
Est. completion
2030-09
Design
Quadruple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗