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

RecruitingPhase 3Ages 18 Years - anyAllargenx
NCT07091630 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 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

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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 (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 Exclusion Criteria: * Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Sensory CIDP (including sensory-predominant CIDP) * Polyneuropathy of other causes * Clinical diagnosis of systemic lupus erythematosus (SLE) * Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
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What it tests

  • Empasiprubart IV
  • Placebo IV
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Where

89 sites
University of Alabama at Birmingham - 1720 University Blvd
Birmingham, United States
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, United States
Colorado Springs Neurological Associates
Colorado Springs, United States
Medstar Health Research Institute
Washington D.C., United States
Gables Neurology
Miami, United States
Aqualane Clinical Research
Naples, United States
Vero Beach Neurology and Research Institute
Vero Beach, United States
Paradigm Health System
Slidell, United States

…and 81 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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