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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
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).
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, 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
Locations
United States
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Homestead Associates in Research Inc
RECRUITING
Homestead
Visionary Investigators Network
RECRUITING
Miami
Maryland
Erlanger Health System
RECRUITING
Columbia
Texas
NeuroCarePlus
RECRUITING
Houston
National Neuromuscular Research Institute
RECRUITING
Irving
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date:2025-08-22
Estimated Completion Date:2030-09
Participants
Target number of participants:218
Treatments
Experimental: Part A - empasiprubart + IVIg-placebo
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
Active_comparator: Part A - IVIg + empasiprubart-placebo
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
Experimental: Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.