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
argenx
Summary
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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, 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 Criteria: * Besides the indication under study, known autoimmune disease or any medica…
Interventions
- Biologicalempasiprubart
Intravenous infusion of empasiprubart
- BiologicalIVIg
Intravenous infusion of IVIg
- Otherempasiprubart-placebo
A placebo resembling the empasiprubart treatment
- OtherIVIg-placebo
A placebo resembling the IVIg treatment
Locations (73)
- Samir Macwan, M.D., Inc.Rancho Mirage, California
- Colorado Springs Neurological AssociatesColorado Springs, Colorado
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- Homestead Associates in Research IncHomestead, Florida
- Visionary Investigators NetworkMiami, Florida
- University of South FloridaTampa, Florida