A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC

NCT06637072 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: ARGX-113-2406
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period

  Up to 12 weeks

Secondary Outcomes (5)

• Changes from baseline in EQ-5D-5L scores over time

  Up to 12 weeks

• Changes from baseline in TSQM-9 scores over time

  Up to 12 weeks

• Changes from baseline in PGI-C scores over time

  Up to 12 weeks

• Changes from baseline in PGI-S scores over time

  Up to 12 weeks

• Incidence of (S)AEs

  Up to 16 weeks

Study Arms (1)

Efgartigimod PH20 SC

EXPERIMENTAL

Participants start efgartigimod PH20 SC treatment after discontinuing IVIg

Biological: Efgartigimod PH20 SC

Interventions

Efgartigimod PH20 SC BIOLOGICAL

Subcutaneous injection of efgartigimod PH20 SC

Efgartigimod PH20 SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (13)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

Visionary Investigators Network

Miami, Florida, 33180, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Velocity Clinical Research

Lafayette, Louisiana, 70508, United States

Location

SRI International - ClinEdge

Plymouth, Michigan, 48170, United States

Location

Velocity Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Erlanger Neuroscience Institute

Chattanooga, Tennessee, 37403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

National Neuromuscular Research Institute

Austin, Texas, 78759, United States

Location

Horizon Clinical Research: Gill Neuroscience

Cypress, Texas, 21216, United States

Location

Northwest Houston Neurology - Cypress

Cypress, Texas, 77429, United States

Location

Cedar Health Research - Dallas

Dallas, Texas, 75251, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: December 10, 2024
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)