A Study to Assess Adults with CIDP Transitioning from IVIg to Efgartigimod PH20 SC

Last updated: January 24, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

4

Condition

Peripheral Neuropathy

Treatment

Efgartigimod PH20 SC

Clinical Study ID

NCT06637072
ARGX-113-2406
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 theEuropean 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 20mg 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 stabledose for at least 3 months

Exclusion

Exclusion Criteria:

  • Besides the indication under study, known autoimmune disease or any medicalcondition that would interfere with an accurate assessment of clinical symptoms ofCIDP or puts the participant at undue risk

  • Types of other polyneuropathy other than CIDP

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Efgartigimod PH20 SC
Phase: 4
Study Start date:
December 10, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Miami, Florida 33180
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas 78759
    United States

    Active - Recruiting

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