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

NCT04777734 | Unknown

• 1 other identifier: ARGX-113-PAA-2403
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); CIDP

Interventions

Efgartigimod PH20 SC BIOLOGICAL

Subcutaneous administration of Efgartigimod PH20 (via vial or prefilled syringe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (6)