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

NCT07091630 · tracked via the Priya Life Science Czechia tracker

Sponsor

argenx

Phase

Phase 3

Started

2025-09-16

Last updated

2026-09-24

Condition(s) studied

Chronic Inflammatory Demyelinating PolyneuropathyCIDPChronic Inflammatory Demyelinating Polyradiculoneuropathy

Investigational drug(s) / intervention(s)

Empasiprubart IV →Placebo IV

Empasiprubart IV: Intravenous infusion of empasiprubart

Placebo IV: Intravenous infusion of placebo

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

Sex

ALL

Min age

18 Years

Max age

—

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 (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

Primary outcome measure(s)

Reduction of ≥1 point compared with baseline in aINCAT score at week 24 — Up to 24 weeks
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).

Trial sites (85)

Facility	City	Region	Status
University of Alabama at Birmingham - 1720 University Blvd	Birmingham	Alabama	Recruiting
Samir Macwan, M.D., Inc. (S corporation)	Rancho Mirage	California	Recruiting
Colorado Springs Neurological Associates	Colorado Springs	Colorado	Recruiting
Medstar Health Research Institute	Washington D.C.	District of Columbia	Recruiting
Gables Neurology	Miami	Florida	Recruiting
Aqualane Clinical Research	Naples	Florida	Recruiting
Paradigm Health System	Slidell	Louisiana	Recruiting
Penn Medicine University City	Philadelphia	Pennsylvania	Recruiting
Jefferson Health Honickman Center	Philadelphia	Pennsylvania	Recruiting
University Neurology	Knoxville	Tennessee	Recruiting
National Neuromuscular Research Institute	Austin	Texas	Recruiting
NeuroCarePlus	Houston	Texas	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	Recruiting
Universitätsklinikum AKH Wien	Vienna	Austria	Recruiting
Unidade de Pesquisa Clinica e Inovacao da Estacio	Rio de Janeiro	Rio de Janeiro	Recruiting
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS	Pôrto Alegre	Rio Grande do Sul	Recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS	Ribeirão Preto	São Paulo	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	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	Recruiting
The People's Hospital of Baiyun District Guangzhou	Guangzhou	Guangdong	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	Recruiting
AP-HP - Hôpital de la Pitié Salpétrière	Paris	Paris	Recruiting
AP-HP - Hôpital Henri Mondor	Créteil	Val-de-Marne	Recruiting

+ 45 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting

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

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07091630 on ClinicalTrials.gov ↗ ← All trials in Czechia