Empasiprubart versus IVIg for treating CIDP in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial randomizes adults with CIDP who are on maintenance IVIg to receive either empasiprubart with an IVIg-matching placebo or IVIg with an empasiprubart-matching placebo for 24 weeks (Part A). After Part A, all participants enter an open-label extension (Part B) in which everyone receives empasiprubart for 96 weeks. Eligible participants must meet the 2021 EAN/PNS CIDP diagnostic criteria, have active disease with residual disability, and have responded to IVIg within the past five years. The trial compares clinical efficacy and safety during the blinded period and monitors longer-term outcomes during the open-label phase.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Banner University of Arizona Medical Center
  Tucson, Arizona, United States Recruiting
• Samir Macwan, M.D., Inc.
  Rancho Mirage, California, United States Recruiting
• Colorado Springs Neurological Associates
  Colorado Springs, Colorado, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Homestead Associates in Research Inc
  Homestead, Florida, United States Recruiting

+57 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Empasiprubart for adults with CIDP

  This study will test whether IV empasiprubart helps improve symptoms and is safe for adults with CIDP, with an initial 24-week randomized comparison to placebo followed by two years of empasiprubart for all participants.

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• Comparing IVIG and SCIG dosing for CIDP

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• Multimodal Movement Tracking in CIDP

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• KITE-363 treatment for relapsed or refractory autoimmune neurologic diseases

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• Using a smartwatch to monitor subcutaneous immunoglobulin treatment in CIDP

  This project will test whether smartwatch data like step counts and activity levels can show disease severity and treatment response in adults with CIDP who are switching from IVIG to subcutaneous immunoglobulin (fSCIG).

  Recruiting at 2 sites Heinrich-Heine University, Duesseldorf · Düsseldorf, North Rhine-Westphalia and 1 other locations · NCT07273903

• Real-world efgartigimod use in adults with CIDP

  This study will see if efgartigimod helps adults with CIDP when given as part of routine clinical care.

  Recruiting at 22 sites argenx · Wilmington, North Carolina and 22 other locations · NCT07264426

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.