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NCT07091630From ClinicalTrials.govRecruiting

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

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

  • Chronic Inflammatory Demyelinating Polyneuropathy
  • CIDP
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
argenx
Enrolment target
160
Started
16 September 2025
Main results due
7 October 2027
Study sites
85
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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 (including motor-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 CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP

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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(85)

  • University of Alabama at Birmingham - 1720 University Blvd

    Birmingham, Alabama, United States

    Recruiting

  • Samir Macwan, M.D., Inc. (S corporation)

    Rancho Mirage, California, United States

    Recruiting

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, United States

    Recruiting

  • Medstar Health Research Institute

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

    Recruiting

  • Gables Neurology

    Miami, Florida, United States

    Recruiting

  • Aqualane Clinical Research

    Naples, Florida, United States

    Recruiting

  • Paradigm Health System

    Slidell, Louisiana, United States

    Recruiting

  • Penn Medicine University City

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Jefferson Health Honickman Center

    Philadelphia, Pennsylvania, United States

    Recruiting

  • University Neurology

    Knoxville, Tennessee, United States

    Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas, United States

    Recruiting

  • NeuroCarePlus

    Houston, Texas, United States

    Recruiting

  • Instituto Privado Kremer

    Córdoba, Argentina

    Recruiting

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Argentina

    Recruiting

  • INECO Neurociencias Oroño

    Rosario, Argentina

    Recruiting

  • Kepler Universitätsklinikum Linz - Med Campus III

    Linz, Upper Austria, Austria

    Recruiting

  • Universitätsklinikum AKH Wien

    Vienna, Austria

    Recruiting

  • Unidade de Pesquisa Clinica e Inovacao da Estacio

    Rio de Janeiro, Rio de Janeiro, Brazil

    Recruiting

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Pôrto Alegre, Rio Grande do Sul, Brazil

    Recruiting

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS

    Ribeirão Preto, São Paulo, Brazil

    Recruiting

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Brazil

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Brazil

    Recruiting

  • PSEG Centro de Pesquisa Clinica

    São Paulo, Brazil

    Recruiting

  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

    Sofia, Sofia, Bulgaria

    Recruiting

  • University Multiprofile Hospital for Active Treatment

    Pleven, Bulgaria

    Recruiting

  • Medical Center Medika 2005 - Branch Sofia

    Sofia, Bulgaria

    Recruiting

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia, Bulgaria

    Recruiting

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

    Sofia, Bulgaria

    Recruiting

  • Fujian Medical University Union Hospital - Yushan Campus

    Fuzhou, Fujian, China

    Recruiting

  • The People's Hospital of Baiyun District Guangzhou

    Guangzhou, Guangdong, China

    Recruiting

  • Peking University First Hospital - Changqiao Campus

    Beijing, China

    Recruiting

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, China

    Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, China

    Recruiting

  • Xi'an Gaoxin Hospital

    Xi'an, China

    Recruiting

  • Fakultni nemocnice Brno

    Brno, Czechia

    Recruiting

  • Rigshospitalet

    Copenhagen, Denmark

    Recruiting

  • Astra Kliinik

    Tallinn, Estonia

    Recruiting

  • CHU de Lille - Hôpital Roger Salengro

    Lille, Nord, France

    Recruiting

  • AP-HP - Hôpital de la Pitié Salpétrière

    Paris, Paris, France

    Recruiting

  • AP-HP - Hôpital Henri Mondor

    Créteil, Val-de-Marne, France

    Recruiting

  • CHU de Bordeaux - Hôpital

    Bourdeaux, France

    Recruiting

  • CHU de Nice-Hôpital Pasteur

    Nice, France

    Recruiting

  • High Technology Hospital MedCenter Ltd

    Batumi, Georgia

    Recruiting

  • First Medical Clinic LLC

    Batumi, Georgia

    Recruiting

  • Petre Sarajishvili Institute of Neurology

    Tbilisi, Georgia

    Recruiting

  • Aleksandre Aladashvili Clinic

    Tbilisi, Georgia

    Recruiting

  • Curatio JSC

    Tbilisi, Georgia

    Recruiting

  • LTD New Hospitals

    Tbilisi, Georgia

    Recruiting

  • Geo Hospitals

    Tbilisi, Georgia

    Recruiting

  • Jo Ann Medical Center

    Tbilisi, Georgia

    Recruiting

  • University General Hospital of Alexandroupolis

    Alexandroupoli, Evros, Greece

    Recruiting

  • Eginitio Hospital

    Athens, Greece

    Recruiting

  • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

    Budapest, Hungary

    Recruiting

  • Hillel Yaffe Medical Center

    Hadera, Israel

    Recruiting

  • The Chaim Sheba Medical Center - PPDS

    Ramat Gan, Israel

    Recruiting

  • Fondazione Serena Onlus - Centro Clinico NeMO Brescia

    Gussago, Brescia, Italy

    Recruiting

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara

    Trieste, Friuli-VeneziaGiulia, Italy

    Recruiting

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, Italy

    Recruiting

  • IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

    Genova, Italy

    Recruiting

  • Ospedale San Raffaele S.r.l.

    Milan, Italy

    Recruiting

Showing 60 of 85 sites — filter to narrow it down. 85 of the 85 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07091630. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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