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New CIDP drug empasiprubart enters final phase of testing

NCT ID NCT07091630

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether empasiprubart, given by IV infusion, can help adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a nerve disorder that causes weakness and disability. The study will enroll 160 participants. For the first 6 months, some get the drug and some get a placebo; after that, everyone receives empasiprubart for 2 years. The main goal is to see if the drug reduces disability scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empasiprubart (a biologic drug given by IV infusion)
What this could lead to
If it works, this could provide a new treatment option for CIDP that reduces disability and improves daily function.
What could go wrong
This is a phase 3 trial, but it is still experimental. The drug may not prove better than placebo, and side effects are possible. Results may not apply to all CIDP patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy polyneuropathy, inflammatory demyelinating, chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyradiculoneuropathy CIDP

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    62 sites in 22 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AP-HP - Hôpital Henri Mondor

    ACTIVE_NOT_RECRUITING

    Créteil, Val-de-Marne, 94000, France

  • AP-HP - Hôpital de la Pitié Salpétrière

    ACTIVE_NOT_RECRUITING

    Paris, Paris, 75013, France

  • Aleksandre Aladashvili Clinic

    RECRUITING

    Tbilisi, 102, Georgia

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Astra Kliinik

    RECRUITING

    Tallinn, 11315, Estonia

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

    ACTIVE_NOT_RECRUITING

    Trieste, Friuli-VeneziaGiulia, 34149, Italy

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

    RECRUITING

    Trieste, 34149, Italy

  • CHU de Bordeaux - Hôpital

    NOT_YET_RECRUITING

    Bourdeaux, France

    Contact Email: •••••@•••••

  • CHU de Lille - Hôpital Roger Salengro

    ACTIVE_NOT_RECRUITING

    Lille, Nord, 59000, France

  • CHU de Nice-Hôpital Pasteur

    RECRUITING

    Nice, 6001, France

  • Centrum Medyczne Neurologia Slaska

    RECRUITING

    Katowice, 40-689, Poland

  • Colorado Springs Neurological Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Curatio JSC

    RECRUITING

    Tbilisi, 114, Georgia

  • Eginitio Hospital

    RECRUITING

    Athens, Greece

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, 625 00, Czechia

  • First Medical Clinic LLC

    RECRUITING

    Batumi, Georgia

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Serena Onlus - Centro Clinico NeMO Brescia

    ACTIVE_NOT_RECRUITING

    Gussago, Brescia, 25064, Italy

  • Fujian Medical University Union Hospital - Yushan Campus

    ACTIVE_NOT_RECRUITING

    Fuzhou, Fujian, 350108, China

  • Gables Neurology

    RECRUITING

    Miami, Florida, 33133, United States

  • Galen Clinic - Warszawa

    ACTIVE_NOT_RECRUITING

    Warsaw, Poland

  • Geo Hospitals

    RECRUITING

    Tbilisi, 144, Georgia

  • Guangdong Provincial Hospital of Chinese Medicine

    RECRUITING

    Guangzhou, 510120, China

  • High Technology Hospital MedCenter Ltd

    RECRUITING

    Batumi, 6000, Georgia

  • Hillel Yaffe Medical Center

    RECRUITING

    Hadera, 3820302, Israel

  • Hospital Moinhos de Vento

    RECRUITING

    Porto Alegre, 90560-032, Brazil

  • INECO Neurociencias Oroño

    ACTIVE_NOT_RECRUITING

    Rosario, Argentina

  • IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    RECRUITING

    Bologna, 40139, Italy

  • Institute of Science Tokyo Hospital

    ACTIVE_NOT_RECRUITING

    Bunkyō-Ku, Tokyo, 113-8519, Japan

  • Instituto Médico de la Fundación Estudios Clínicos

    RECRUITING

    Rosario, S2000DEJ, Argentina

  • Instituto Privado Kremer

    RECRUITING

    Córdoba, X5004AOA, Argentina

  • Institutul de Neurologie si Neurochirurgie

    RECRUITING

    Chisinau, 2028, Moldova

  • Institutul de Neurologie si Neurochirurgie

    RECRUITING

    Chisinau, 2028, Moldova

  • Jefferson Health Honickman Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • Jo Ann Medical Center

    RECRUITING

    Tbilisi, 159, Georgia

  • Kepler Universitätsklinikum Linz - Med Campus III

    ACTIVE_NOT_RECRUITING

    Linz, Upper Austria, 4021, Austria

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08308, South Korea

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    RECRUITING

    Brasília, 70200-730, Brazil

  • LTD New Hospitals

    RECRUITING

    Tbilisi, 114, Georgia

  • Medical Center Medika 2005 - Branch Sofia

    RECRUITING

    Sofia, 1164, Bulgaria

  • Medstar Health Research Institute

    RECRUITING

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

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

    ACTIVE_NOT_RECRUITING

    Sofia, Sofia, 1113, Bulgaria

  • Nanfang Hospital Southern Medical University

    RECRUITING

    Guangzhou, 510515, China

  • National Neuromuscular Research Institute

    RECRUITING

    Austin, Texas, 78756, United States

  • National Neuroscience Institute

    ACTIVE_NOT_RECRUITING

    Singapore, Singapore

  • Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals

    RECRUITING

    Michalovce, 071 01, Slovakia

  • NeuroCarePlus

    RECRUITING

    Houston, Texas, 77094, United States

  • Ospedale San Raffaele S.r.l.

    RECRUITING

    Milan, 20132, Italy

  • PSEG Centro de Pesquisa Clinica

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Paradigm Health System

    RECRUITING

    Slidell, Louisiana, 70458, United States

  • Peking University First Hospital - Changqiao Campus

    RECRUITING

    Beijing, 100034, China

  • Penn Medicine University City

    RECRUITING

    Philadelphia, Pennsylvania, 19104-5545, United States

  • Penta Hospitals SK, a.s. - Rimavská Sobota

    RECRUITING

    Rimavská Sobota, 979 01, Slovakia

  • Petre Sarajishvili Institute of Neurology

    RECRUITING

    Tbilisi, 0112, Georgia

  • Queen's Medical Centre

    ACTIVE_NOT_RECRUITING

    Nottingham, Nottinghamshire, NG72UH, United Kingdom

  • Regina Maria Brasov Hospital

    RECRUITING

    Brasov, 500091, Romania

  • Rigshospitalet

    ACTIVE_NOT_RECRUITING

    Copenhagen, 2100, Denmark

  • S.C. Neurocity S.R.L

    RECRUITING

    Bucharest, Romania

  • SC Clubul Sanatatii SRL

    RECRUITING

    Campulung Muscel, 115100, Romania

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    RECRUITING

    Krakow, 30-688, Poland

  • Saga University Hospital

    RECRUITING

    Saga, 849-0937, Japan

  • Salford Royal Hospital

    RECRUITING

    Salford, M6 8HD, United Kingdom

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

    RECRUITING

    Rancho Mirage, California, 92270, United States

  • Seirei Hamamatsu Hospital

    RECRUITING

    Hiroshima, 430-8558, Japan

  • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

    RECRUITING

    Budapest, 1082, Hungary

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Southern TOHOKU Medical Clinic

    RECRUITING

    Kōriyama, 963-8052, Japan

  • Spitalul Judetean de Urgenta Deva

    RECRUITING

    Deva, 330084, Romania

  • The Chaim Sheba Medical Center - PPDS

    ACTIVE_NOT_RECRUITING

    Ramat Gan, 52621, Israel

  • The National Hospital for Neurology and Neurosurgery - PPDS

    ACTIVE_NOT_RECRUITING

    London, WC1N3BG, United Kingdom

  • The People's Hospital of Baiyun District Guangzhou

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510440, China

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University General Hospital of Alexandroupolis

    ACTIVE_NOT_RECRUITING

    Alexandroupoli, Evros, 68100, Greece

  • University Multiprofile Hospital for Active Treatment

    RECRUITING

    Pleven, 5803, Bulgaria

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    RECRUITING

    Sofia, 1431, Bulgaria

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

    RECRUITING

    Sofia, 1606, Bulgaria

  • University Neurology

    ACTIVE_NOT_RECRUITING

    Knoxville, Tennessee, 37920-1511, United States

  • University of Alabama at Birmingham - 1720 University Blvd

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35233, United States

  • Universitätsklinikum AKH Wien

    RECRUITING

    Vienna, 1090, Austria

  • Univerzitna nemocnica MARTIN

    RECRUITING

    Martin, 036 59, Slovakia

  • Xi'an Gaoxin Hospital

    RECRUITING

    Xi'an, 710075, China

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