A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy Who Transition From Treatment With Intravenous Immunoglobulin to Efgartigimod PH20 SC
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Is at least 18 years of age and the local legal age of consent
• Is diagnosed with CIDP (confirmed or possible CIDP) according to the criteria of the European Academy of Neurology/Peripheral Nerve Society
• Is being treated with IVIg every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses
• If receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month.
• If receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months
Locations
United States
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Neurology Associates PA
RECRUITING
Maitland
Visionary Investigators Network
RECRUITING
Miami
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Louisiana
Velocity Clinical Research
RECRUITING
Lafayette
Michigan
SRI International - ClinEdge
RECRUITING
Plymouth
North Carolina
Velocity Clinical Research
RECRUITING
Raleigh
Tennessee
Erlanger Neuroscience Institute
RECRUITING
Chattanooga
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
Horizon Clinical Research: Gill Neuroscience
RECRUITING
Cypress
Northwest Houston Neurology - Cypress
RECRUITING
Cypress
Cedar Health Research - Dallas
RECRUITING
Dallas
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date:2024-12-10
Estimated Completion Date:2026-02
Participants
Target number of participants:25
Treatments
Experimental: Efgartigimod PH20 SC
Participants start efgartigimod PH20 SC treatment after discontinuing IVIg