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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06637072

Enrollment

Registered

2024-10-15

Start date

2024-12-10

Completion date

2026-02-19

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

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.

Interventions

BIOLOGICALEfgartigimod PH20 SC

Subcutaneous injection of efgartigimod PH20 SC

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026