Find Chronic Polyradiculoneuritis Clinical Trials Near You
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP
Locations
United States
Colorado
Colorado Springs Neurological Associates
RECRUITING
Colorado Springs
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
Gables Neurology
RECRUITING
Miami
Louisiana
Paradigm Health System
RECRUITING
Slidell
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
NeuroCarePlus
RECRUITING
Houston
Other Locations
China
Peking University First Hospital - Changqiao Campus
RECRUITING
Beijing
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
Georgia
First Medical Clinic LLC
RECRUITING
Batumi
High Technology Hospital MedCenter Ltd
RECRUITING
Batumi
Aleksandre Aladashvili Clinic
RECRUITING
Tbilisi
Curatio JSC
RECRUITING
Tbilisi
Geo Hospitals
RECRUITING
Tbilisi
Jo Ann Medical Center
RECRUITING
Tbilisi
LTD New Hospitals
RECRUITING
Tbilisi
Petre Sarajishvili Institute of Neurology
RECRUITING
Tbilisi
Japan
Southern TOHOKU Medical Clinic
RECRUITING
Kōriyama
Republic of Korea
Korea University Guro Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date:2025-09-16
Estimated Completion Date:2031-01-23
Participants
Target number of participants:160
Treatments
Experimental: Part A - Empasiprubart
Participants receive empasiprubart during part A
Placebo_comparator: Part A - Placebo
Participants receive placebo during part A
Experimental: Part B - Empasiprubart
Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.