A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
argenx
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
- Age range
- 18+ years
- Sex
- All
- 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 we…
Interventions
- BiologicalEmpasiprubart
Intravenous infusion of empasiprubart
- BiologicalIVIG (Intravenous Immunoglobulin)
Intravenous infusion of IVIg
- OtherEmpasiprubart-placebo
A placebo resembling the empasiprubart treatment
- OtherIVIg-placebo
A placebo resembling the IVIg treatment
Locations (109)
- HonorHealth Neurology - Bob Bove Neuroscience Institute - NeurologyScottsdale, Arizona
- The Neurology GroupPomona, California
- Samir Macwan, M.D., Inc.Rancho Mirage, California
- University of California San FranciscoSan Francisco, California
- University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic)Aurora, Colorado
- Yale University School of MedicineNew Haven, Connecticut