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The trial is taking place at:
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National Neuromuscular Research Institute | Austin, TX

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

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Status and phase

Enrolling
Phase 4

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Treatments

Biological: Efgartigimod PH20 SC

Study type

Interventional

Funder types

Industry

Identifiers

NCT06637072
ARGX-113-2406

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

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
  • Types of other polyneuropathy other than CIDP

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Efgartigimod PH20 SC
Experimental group
Description:
Participants start efgartigimod PH20 SC treatment after discontinuing IVIg
Treatment:
Biological: Efgartigimod PH20 SC

Trial contacts and locations

3

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Central trial contact

Sabine Coppieters, MD

Data sourced from clinicaltrials.gov

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