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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

In brief

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart 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/emvigorate

Key facts

Study ID

NCT06920004

Run by

argenx

People needed

218

Starts

2025-08-22

Expected to finish

2030-09-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
• Has responded to IVIg in the past 5 years
• Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
• Has residual disability and active disease

You may not qualify if…

• Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes
• Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
• Use of other long-acting immunomodulatory treatment

Where it is running

• University of Alabama — Birmingham, Alabama, United States (enrolling)
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Samir Macwan, M.D., Inc. — Rancho Mirage, California, United States (enrolling)
• Visionary Investigators Network — Miami, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Paradigm Health System — Slidell, Louisiana, United States (enrolling)
• Erlanger Health System — Columbia, Maryland, United States (enrolling)
• Homestead Associates in Research Inc — Homestead, Florida, United States (enrolling)
• NeuroCarePlus — Houston, Texas, United States (enrolling)
• National Neuromuscular Research Institute — Irving, Texas, United States (enrolling)
• INECO Neurociencias Oroño — Rosario, Argentina (enrolling)
• Universitätsklinikum AKH Wien — Vienna, Austria (enrolling)
• Hospital Universitario San Ignacio — Bogotá, Colombia (enrolling)
• Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico — Medellín, Colombia (enrolling)
• Fakultni nemocnice Brno — Brno, Czechia (enrolling)
• Astra Kliinik — Tallinn, Estonia (enrolling)
• Tartu University Hospital — Tartu, Estonia (enrolling)
• University of Michigan Hospital — Ann Arbor, Michigan, United States (enrolling)
• CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (enrolling)
• AP-HP - Hôpital Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
• CHU de Nice-Hôpital Pasteur — Nice, France (enrolling)
• CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg, France (enrolling)
• CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan — Toulouse, France (enrolling)
• Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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