Loading clinical trials...

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06920004•argenx

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (46)

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Homestead Associates in Research Inc

Homestead, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Paradigm Health System

Slidell, Louisiana, United States

Erlanger Health System

Columbia, Maryland, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

NeuroCarePlus

Houston, Texas, United States

National Neuromuscular Research Institute

Irving, Texas, United States

Key Dates

Start Date

August 22, 2025

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2030

Last Updated

March 6, 2026

Enrollment

218

ESTIMATED participants

Conditions

Chronic Inflammatory Demyelinating PolyneuropathyCIDPCIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

empasiprubart

BIOLOGICAL

IVIg

BIOLOGICAL

empasiprubart-placebo

OTHER

IVIg-placebo

OTHER

Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834 clinicaltrials@argenx.com

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

NCT06752356

Chronic Inflammatory Demyelinating Polyneuropathy

View study

RECRUITING

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

NCT07264426

Chronic Inflammatory Demyelinating PolyradiculoneuropathyCIDP+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care

Biorepository and Registry for Plasma Exchange Patients

A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy