A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
argenx
Summary
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo 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/emnergize
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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP * Has residual disability and active disease * Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors) * Participants already receiving CIDP treatment will…
Interventions
- BiologicalEmpasiprubart IV
Intravenous infusion of empasiprubart
- OtherPlacebo IV
Intravenous infusion of placebo
Locations (43)
- Samir Macwan, M.D., Inc. (S corporation)Rancho Mirage, California
- Colorado Springs Neurological AssociatesColorado Springs, Colorado
- Medstar Health Research InstituteWashington D.C., District of Columbia
- Gables NeurologyMiami, Florida
- Aqualane Clinical ResearchNaples, Florida
- Paradigm Health SystemSlidell, Louisiana