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

NCT07091630 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ARGX-117-24022025-520805-10-00
• Study Type: interventional
• Target: 160
• Locations: 23 countries
• Sites: 71

Brief 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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy; CIDP; Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Outcome Measures

Primary Outcomes (1)

• Reduction of ≥1 point compared with baseline in aINCAT score at week 24

  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).

  Up to 24 weeks

Secondary Outcomes (22)

• Change from baseline in I-RODS centile points score

  Up to 24 weeks (part A) + 96 weeks (Part B)

• Change from baseline in MRC-SS at week 24

  Up to 24 weeks

• Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24

  Up to 24 weeks

• Time to reduction of ≥1 point from baseline in aINCAT score

  Up to 24 weeks

• Change from baseline in TUG

  Up to 24 weeks (part A) + 96 weeks (Part B)

Study Arms (3)

Part A - Empasiprubart

EXPERIMENTAL

Participants receive empasiprubart during part A

Biological: Empasiprubart IV

Part A - Placebo

PLACEBO COMPARATOR

Participants receive placebo during part A

Other: Placebo IV

Part B - Empasiprubart

EXPERIMENTAL

Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.

Biological: Empasiprubart IV

Interventions

Empasiprubart IV BIOLOGICAL

Intravenous infusion of empasiprubart

Part A - Empasiprubart; Part B - Empasiprubart

Placebo IV OTHER

Intravenous infusion of placebo

Part A - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (71)

University of Alabama at Birmingham - 1720 University Blvd

Birmingham, Alabama, 35233, United States

ACTIVE NOT RECRUITING

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

Rancho Mirage, California, 92270, United States

RECRUITING

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Medstar Health Research Institute

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

RECRUITING

Gables Neurology

Miami, Florida, 33133, United States

RECRUITING

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

Paradigm Health System

Slidell, Louisiana, 70458, United States

RECRUITING

Penn Medicine University City

Philadelphia, Pennsylvania, 19104-5545, United States

RECRUITING

National Neuromuscular Research Institute

Austin, Texas, 78756, United States

RECRUITING

NeuroCarePlus

Houston, Texas, 77094, United States

RECRUITING

Instituto Privado Kremer

Córdoba, X5004AOA, Argentina

RECRUITING

Instituto Médico de la Fundación Estudios Clínicos

Rosario, S2000DEJ, Argentina

RECRUITING

INECO Neurociencias Oroño

Rosario, Argentina

ACTIVE NOT RECRUITING

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria, 4021, Austria

ACTIVE NOT RECRUITING

Universitätsklinikum AKH Wien

Vienna, 1090, Austria

RECRUITING

PSEG Centro de Pesquisa Clinica

São Paulo, 04038-002, Brazil

RECRUITING

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

Sofia, Sofia, 1113, Bulgaria

ACTIVE NOT RECRUITING

University Multiprofile Hospital for Active Treatment

Pleven, 5803, Bulgaria

RECRUITING

Medical Center Medika 2005 - Branch Sofia

Sofia, 1164, Bulgaria

RECRUITING

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

Sofia, 1431, Bulgaria

RECRUITING

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

Sofia, 1606, Bulgaria

RECRUITING

Fujian Medical University Union Hospital - Yushan Campus

Fuzhou, Fujian, 350108, China

ACTIVE NOT RECRUITING

Peking University First Hospital - Changqiao Campus

Beijing, 100034, China

RECRUITING

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, 510120, China

RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, 510515, China

RECRUITING

Xi'an Gaoxin Hospital

Xi'an, 710075, China

RECRUITING

Fakultni nemocnice Brno

Brno, 625 00, Czechia

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

ACTIVE NOT RECRUITING

Astra Kliinik

Tallinn, 11315, Estonia

RECRUITING

CHU de Lille - Hôpital Roger Salengro

Lille, Nord, 59000, France

ACTIVE NOT RECRUITING

AP-HP - Hôpital de la Pitié Salpétrière

Paris, Paris, 75013, France

ACTIVE NOT RECRUITING

AP-HP - Hôpital Henri Mondor

Créteil, Val-de-Marne, 94000, France

ACTIVE NOT RECRUITING

CHU de Bordeaux - Hôpital

Bourdeaux, France

NOT YET RECRUITING

CHU de Nice-Hôpital Pasteur

Nice, 6001, France

RECRUITING

High Technology Hospital MedCenter Ltd

Batumi, 6000, Georgia

RECRUITING

First Medical Clinic LLC

Batumi, Georgia

RECRUITING

Petre Sarajishvili Institute of Neurology

Tbilisi, 0112, Georgia

RECRUITING

Aleksandre Aladashvili Clinic

Tbilisi, 102, Georgia

RECRUITING

Curatio JSC

Tbilisi, 114, Georgia

RECRUITING

LTD New Hospitals

Tbilisi, 114, Georgia

RECRUITING

Geo Hospitals

Tbilisi, 144, Georgia

RECRUITING

Jo Ann Medical Center

Tbilisi, 159, Georgia

RECRUITING

University General Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

ACTIVE NOT RECRUITING

Eginitio Hospital

Athens, Greece

RECRUITING

Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

Budapest, 1082, Hungary

RECRUITING

Fondazione Serena Onlus - Centro Clinico NeMO Brescia

Gussago, Brescia, 25064, Italy

ACTIVE NOT RECRUITING

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

Trieste, Friuli-VeneziaGiulia, 34149, Italy

ACTIVE NOT RECRUITING

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, 40139, Italy

RECRUITING

IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

Genova, 16132, Italy

RECRUITING

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

RECRUITING

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100, Italy

RECRUITING

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo, 113-8519, Japan

ACTIVE NOT RECRUITING

Seirei Hamamatsu Hospital

Hiroshima, 430-8558, Japan

RECRUITING

Southern TOHOKU Medical Clinic

Kōriyama, 963-8052, Japan

RECRUITING

Saga University Hospital

Saga, 849-0937, Japan

RECRUITING

Institutul de Neurologie si Neurochirurgie

Chisinau, 2028, Moldova

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Centrum Medyczne Neurologia Slaska

Katowice, 40-689, Poland

RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

RECRUITING

Galen Clinic - Warszawa

Warsaw, Poland

ACTIVE NOT RECRUITING

S.C. Neurocity S.R.L

Bucharest, Romania

RECRUITING

SC Clubul Sanatatii SRL

Campulung Muscel, 115100, Romania

RECRUITING

Spitalul Judetean de Urgenta Deva

Deva, 330084, Romania

RECRUITING

National Neuroscience Institute

Singapore, Singapore

ACTIVE NOT RECRUITING

Univerzitna nemocnica MARTIN

Martin, 036 59, Slovakia

RECRUITING

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

Michalovce, 071 01, Slovakia

RECRUITING

Penta Hospitals SK, a.s. - Rimavská Sobota

Rimavská Sobota, 979 01, Slovakia

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

The National Hospital for Neurology and Neurosurgery - PPDS

London, WC1N3BG, United Kingdom

ACTIVE NOT RECRUITING

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): October 7, 2027
• Study Completion (Estimated): January 23, 2031
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); GR (2); DK (1); GB (2); MO (1); FR (5); KR (2); JP (4); GE (8); CN (5); US (10); CZ (1); IT (6); RO (3); PL (3); BU (5); AU (2); ES (1); SL (3); AR (3); NL (1); BR (1); HU (1)