Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

March 20, 2026 updated by: argenx

Pre-Approval Access for Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options. The program will continue until the patient discontinues treatment or until the reimbursement process for CIDP concludes, whichever comes first.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigator site 12 - Approved for Marketing
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Investigator site 16 - Approved for Marketing
    • Michigan
      • Ann Arbor, Michigan, United States, 41809
        • Investigator site 1 - Approved for Marketing
    • New York
      • New Hyde Park, New York, United States, 11042
        • Investigator Site 6 - Approved for Marketing
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigator site 14 - Approved for Marketing
    • Virginia
      • Henrico, Virginia, United States, 23233
        • Investigator site 2 - Approved for Marketing

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Cannot be included in an ongoing clinical study and cannot be satisfactorily treated with a product that has regulatory approval
  • Is ≥18 years of age at the time of signing the informed consent form
  • Patient has a diagnosis of CIDP according to the 2021 EAN/PNS CIDP guidelines
  • Patient has progressive or relapsing active disease after prior treatment with corticosteroids or immunoglobulins

Exclusion Criteria:

  • Known autoimmune disease or any medical condition that, in the opinion of the treating physician, would interfere with an accurate assessment of clinical symptoms of CIDP or that puts the patient at undue risk
  • Is currently being treated or plans to start treatment with monoclonal antibodies or treatments that contain the human Fc domain of the IgG subclass
  • Pregnant or lactating state or intention to become pregnant during the program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-PAA-2403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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