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Clinical Trials in the UK / NCT07091630
Recruiting Phase 3

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

NCT07091630 · tracked via the Priya Life Science UK tracker
Sponsor
argenx
Phase
Phase 3
Started
2025-09-16
Last updated
2026-10-27

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
No
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 (89)

FacilityCityRegionStatus
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
Vero Beach Neurology and Research Institute Vero Beach 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
Escola Bahiana de Medicina e Saude Publica Salvador Estado de Bahia 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
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico Medellín Antioquia Recruiting
Fakultni nemocnice Brno Brno Czechia Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Astra Kliinik Tallinn Estonia Recruiting

+ 49 more sites — see the full list on the official registry below.

More argenx trials in the UK

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation
A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS) Active, not recruiting
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Active, not recruiting
A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy Active, not recruiting
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP) Recruiting

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 Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP Recruiting
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 the UK