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A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

RecruitingPhase 3Ages 18 Years - anyAllargenx
NCT06920004 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). More information can be found here: https://clinicaltrials.argenx.com/emvigorate

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📋 Eligibility rules (as published)
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, 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 Exclusion Criteria: * Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes * Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Use of other long-acting immunomodulatory treatment
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What it tests

  • empasiprubart
  • IVIg
  • empasiprubart-placebo
  • IVIg-placebo
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Where

103 sites
University of Alabama
Birmingham, United States
Samir Macwan, M.D., Inc.
Rancho Mirage, United States
Colorado Springs Neurological Associates
Colorado Springs, United States
MedStar Washington Hospital Center
Washington D.C., United States
Homestead Associates in Research Inc
Homestead, United States
Visionary Investigators Network
Miami, United States
University of South Florida
Tampa, United States
Baptist Health Medical Group Neurology
Nicholasville, United States

…and 95 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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