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

Last updated: March 9, 2026
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

3

Condition

Peripheral Neuropathy

Chronic Inflammatory Demyelinating Polyneuropathy (Cidp)

Treatment

Empasiprubart IV

Placebo IV

Clinical Study ID

NCT07091630
ARGX-117-2402
2025-520805-10-00
  • Ages > 18
  • All Genders

Study Summary

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).

More information can be found here: https://clinicaltrials.argenx.com/emnergize

Eligibility Criteria

Inclusion

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 (includingmotor-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 CIDPtreatment; or is receiving CIDP treatment (pulsed or oral corticosteroids,immunoglobulins, PLEX, or FcRn inhibitors)

  • Participants already receiving CIDP treatment will have to discontinue their CIDPtreatment before first IMP administration and must be willing to switch to the studyIMP

Exclusion

Exclusion Criteria:

  • 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)

  • Use of other long-acting immunomodulatory treatment or prior treatment (at any time)with total lymphoid irradiation or bone marrow transplantation

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Empasiprubart IV
Phase: 3
Study Start date:
September 16, 2025
Estimated Completion Date:
January 23, 2031

Connect with a study center

  • Peking University First Hospital - Changqiao Campus

    Beijing, 100034
    China

    Active - Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, 510515
    China

    Active - Recruiting

  • First Medical Clinic LLC

    Batumi,
    Georgia

    Active - Recruiting

  • High Technology Hospital MedCenter Ltd

    Batumi, 6000
    Georgia

    Active - Recruiting

  • First Medical Clinic LLC

    Batumi 615532,
    Georgia

    Active - Recruiting

  • High Technology Hospital MedCenter Ltd

    Batumi 615532, 6000
    Georgia

    Site Not Available

  • Aleksandre Aladashvili Clinic

    Tbilisi, 102
    Georgia

    Active - Recruiting

  • Curatio JSC

    Tbilisi, 114
    Georgia

    Active - Recruiting

  • Geo Hospitals

    Tbilisi, 144
    Georgia

    Active - Recruiting

  • Jo Ann Medical Center

    Tbilisi, 159
    Georgia

    Active - Recruiting

  • LTD New Hospitals

    Tbilisi, 114
    Georgia

    Active - Recruiting

  • Petre Sarajishvili Institute of Neurology

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Aleksandre Aladashvili Clinic

    Tbilisi 611717, 102
    Georgia

    Site Not Available

  • Curatio JSC

    Tbilisi 611717, 114
    Georgia

    Active - Recruiting

  • Geo Hospitals

    Tbilisi 611717, 144
    Georgia

    Active - Recruiting

  • Jo Ann Medical Center

    Tbilisi 611717, 159
    Georgia

    Active - Recruiting

  • LTD New Hospitals

    Tbilisi 611717, 114
    Georgia

    Active - Recruiting

  • Petre Sarajishvili Institute of Neurology

    Tbilisi 611717, 0112
    Georgia

    Active - Recruiting

  • Southern TOHOKU Medical Clinic

    Kōriyama, 963-8052
    Japan

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 08308
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Colorado Springs Neurological Associates

    Colorado Springs 5417598, Colorado 5417618 80907
    United States

    Site Not Available

  • Medstar Health Research Institute

    Washington D.C., District of Columbia 20010
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Gables Neurology

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Gables Neurology

    Miami 4164138, Florida 4155751 33133
    United States

    Site Not Available

  • Paradigm Health System

    Slidell, Louisiana 70458
    United States

    Active - Recruiting

  • Paradigm Health System

    Slidell 4341727, Louisiana 4331987 70458
    United States

    Site Not Available

  • National Neuromuscular Research Institute

    Austin, Texas 78756
    United States

    Active - Recruiting

  • NeuroCarePlus

    Houston, Texas 77094
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin 4671654, Texas 4736286 78756
    United States

    Site Not Available

  • NeuroCarePlus

    Houston 4699066, Texas 4736286 77094
    United States

    Site Not Available

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