A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

NCT06920004 · tracked via the Priya Life Science USA tracker

Sponsor

argenx

Phase

Phase 3

Started

2025-08-22

Last updated

2026-09-17

Condition(s) studied

Chronic Inflammatory Demyelinating PolyneuropathyCIDPCIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Investigational drug(s) / intervention(s)

empasiprubartIVIgempasiprubart-placeboIVIg-placebo

empasiprubart: Intravenous infusion of empasiprubart

IVIg: Intravenous infusion of IVIg

empasiprubart-placebo: A placebo resembling the empasiprubart treatment

IVIg-placebo: A placebo resembling the IVIg treatment

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Reduction of ≥1 point compared with baseline in aINCAT score at week 24 — up to 24 weeks
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).

Trial sites (95)

Facility	City	Region	Status
University of Alabama	Birmingham	Alabama	Recruiting
Samir Macwan, M.D., Inc.	Rancho Mirage	California	Recruiting
Colorado Springs Neurological Associates	Colorado Springs	Colorado	Recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
Homestead Associates in Research Inc	Homestead	Florida	Recruiting
Visionary Investigators Network	Miami	Florida	Recruiting
University of South Florida	Tampa	Florida	Recruiting
Paradigm Health System	Slidell	Louisiana	Recruiting
Erlanger Health System	Columbia	Maryland	Recruiting
University of Michigan Hospital	Ann Arbor	Michigan	Recruiting
University of Cincinnati Health	Cincinnati	Ohio	Active Not Recruiting
Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania	Recruiting
Jefferson Health Honickman Center	Philadelphia	Pennsylvania	Recruiting
NeuroCarePlus	Houston	Texas	Recruiting
National Neuromuscular Research Institute	Irving	Texas	Recruiting
Instituto Privado Kremer	Córdoba	Argentina	Active Not Recruiting
INECO Neurociencias Oroño	Rosario	Argentina	Recruiting
Liverpool Hospital	Liverpool	New South Wales	Active Not Recruiting
Kepler Universitätsklinikum Linz - Med Campus III	Linz	Austria	Active Not Recruiting
Universitätsklinikum AKH Wien	Vienna	Austria	Recruiting
PSEG Centro de Pesquisa Clinica	São Paulo	Brazil	Recruiting
Black Tusk Research Group	Vancouver	British Columbia	Active Not Recruiting
Hospital Universitario San Ignacio	Bogotá	Colombia	Recruiting
Hospital Alma Máter de Antioquia	Medellín	Colombia	Recruiting
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico	Medellín	Colombia	Recruiting
Fakultni nemocnice Brno	Brno	Czechia	Recruiting
Astra Kliinik	Tallinn	Estonia	Recruiting
Tartu University Hospital	Tartu	Estonia	Recruiting
AP-HP - Hôpital de la Pitié Salpétrière	Paris	Paris	Active Not Recruiting
CHU de Bordeaux - Hôpital Pellegrin	Bordeaux	France	Recruiting
AP-HP - Hôpital Bicêtre	Le Kremlin-Bicêtre	France	Recruiting
CHU de Nice-Hôpital Pasteur	Nice	France	Recruiting
CHU de Strasbourg - Hôpital de Hautepierre	Strasbourg	France	Recruiting
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan	Toulouse	France	Recruiting
Charité - Universitätsmedizin Berlin	Berlin	Germany	Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Germany	Recruiting
University General Hospital of Alexandroupolis	Athens	Greece	Recruiting
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA	Chaïdári	Greece	Recruiting
Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete	Budapest	Hungary	Recruiting
The Barzilai University Medical Center	Ashkelon	Israel	Recruiting

+ 55 more sites — see the full list on the official registry below.

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Other trials for the same condition

Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding. Recruiting

Safety, Tolerability, and Efficacy of NVG-2089 in Participants With CIDP Active, not recruiting

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study Recruiting

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06920004 on ClinicalTrials.gov ↗ ← All trials in the USA