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

Description

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

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Study Overview

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Study Details

Study overview

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.

A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy Who Transition from Treatment with Intravenous Immunoglobulin to Efgartigimod PH20 SC

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

Condition
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention / Treatment

-

Contacts and Locations

Maitland

Neurology Associates PA, Maitland, Florida, United States, 32751

Miami

Visionary Investigators Network, Miami, Florida, United States, 33180

Austin

National Neuromuscular Research Institute, Austin, Texas, United States, 78759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

argenx,

Study Record Dates

2025-09