A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Key facts
- Where
- Ann Arbor, Birmingham, Cincinnati, Colorado Springs, Columbia, Homestead, Houston, Irving, Knoxville, Miami, Nicholasville, Philadelphia, Rancho Mirage, Slidell, Tampa, Tucson, and Washington D.C., United StatesSee the 18 sites
- Phase
- Phase 3
Where in United States
- University of Michigan HospitalAnn Arbor, United StatesTaking people
- University of AlabamaBirmingham, United StatesTaking people
- University of Cincinnati HealthCincinnati, United StatesTaking people
- Colorado Springs Neurological AssociatesColorado Springs, United StatesTaking people
- Erlanger Health SystemColumbia, United StatesTaking people
- Homestead Associates in Research IncHomestead, United StatesTaking people
- NeuroCarePlusHouston, United StatesTaking people
- National Neuromuscular Research InstituteIrving, United StatesTaking people
- University NeurologyKnoxville, United StatesTaking people
- Visionary Investigators NetworkMiami, United StatesTaking people
- Baptist Health Medical Group NeurologyNicholasville, United StatesTaking people
- Jefferson Health Honickman CenterPhiladelphia, United StatesTaking people
- Perelman Center for Advanced MedicinePhiladelphia, United StatesTaking people
- Samir Macwan, M.D., Inc.Rancho Mirage, United StatesTaking people
- Paradigm Health SystemSlidell, United StatesTaking people
- University of South FloridaTampa, United StatesTaking people
- Banner University of Arizona Medical CenterTucson, United StatesTaking people
- MedStar Washington Hospital CenterWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- argenx
- Trial code
- NCT06920004EU 2024-520097-36-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
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
Inclusion: 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.
Exclusion: 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.