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

Phase 4

Recruiting

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
• Interventions: Biological: Efgartigimod PH20 SC

• Registration Number: NCT06637072
• Lead Sponsor: argenx

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Study Start: 2024-12-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Efgartigimod PH20 SC	Efgartigimod PH20 SC	Participants start efgartigimod PH20 SC treatment after discontinuing IVIg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Neurology Associates PA; 🇺🇸 Maitland, Florida, United States

Visionary Investigators Network; 🇺🇸 Miami, Florida, United States

National Neuromuscular Research Institute; 🇺🇸 Austin, Texas, United States