🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT06742190
Active, not recruiting Phase 3

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy

NCT06742190 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Phase 3
Started
2024-12-18
Last updated
2026-09-22

Condition(s) studied

Multifocal Motor Neuropathy (MMN)MMN

Investigational drug(s) / intervention(s)

Empasiprubart →IVIG (Intravenous Immunoglobulin) →Empasiprubart-placeboIVIg-placebo

Empasiprubart: Intravenous infusion of empasiprubart

IVIG (Intravenous Immunoglobulin): Intravenous infusion of IVIg

Empasiprubart-placebo: A placebo resembling the empasiprubart treatment

IVIg-placebo: A placebo resembling the IVIg treatment

Study summary

The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.

More information can be found here: https://clinicaltrials.argenx.com/empassion

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies * Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines * Has responded to IVIg in the past 5 years. * Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle * Is receiving a maintenance regimen (no change in frequency, and no change in dose \>10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks) * Minimum converted weekly IVIg dose of ≥0.125 g/kg * Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration Exclusion Criteria: * Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk * Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)

Primary outcome measure(s)

Trial sites (109)

FacilityCityRegionStatus
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology Scottsdale Arizona
The Neurology Group Pomona California
Samir Macwan, M.D., Inc. Rancho Mirage California
University of California San Francisco San Francisco California
University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic) Aurora Colorado
Yale University School of Medicine New Haven Connecticut
Medstar Health Research Institute Washington D.C. District of Columbia
EZR Research LLC Boca Raton Florida
Healthcare Innovations Institute, LLC Coral Springs Florida
University of Miami Miller School of Medicine Miami Florida
University of South Florida Tampa Florida
Northwestern University Chicago Illinois
Indiana University Health Neuroscience Center Indianapolis Indiana
University of Kansas Medical Center Fairway Kansas
Perelman Center for Advanced Medicine Columbia Maryland
UC Irvine - MDA ALS and Neuromuscular Center Columbia Maryland
University of Minnesota Minneapolis Minnesota
Dent Neurologic Institute Amherst Amherst New York
Columbia University Medical Center New York New York
University of North Carolina at Chapel Hill Morrisville North Carolina
The Cleveland Clinic Foundation Cleveland Ohio
Oregon Health and Science University Portland Oregon
National Neuromuscular Research Institute Austin Texas
NeuroCarePlus Houston Texas
Royal Melbourne Hospital Parkville Australia
Gold Coast University Hospital Southport Australia
Brain and Mind Center Sydney Australia
Princess Alexandra Hospital Woolloongabba Australia
Universitätsklinikum AKH Wien Vienna Austria
UZ Antwerpen Edegem Belgium
UZ Leuven Leuven Belgium
Hôpital de la Citadelle Liège Belgium
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto Ribeirão Preto Brazil
Sociedade de Ensino Superior Estacio de Sa Ltda Rio de Janeiro Brazil
Escola Bahiana de Medicina e Saude Publica Salvador Brazil
PSEG Centro de Pesquisa Clínica São Paulo Brazil
Neuro-Outaouais Clinic Gatineau Canada
London Health Sciences Centre London Canada
St. Paul's Neurology Associates Vancouver Canada
Huashan Hospital Fudan University Shanghai China

+ 69 more sites — see the full list on the official registry below.

More argenx trials in Germany

Other trials for the same condition

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 NCT06742190 on ClinicalTrials.gov ↗ ← All trials in Germany