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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-02-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Efgartigimod PH20 SC

Participants start efgartigimod PH20 SC treatment after discontinuing IVIg

Group Type EXPERIMENTAL

Efgartigimod PH20 SC

Intervention Type BIOLOGICAL

Subcutaneous injection of efgartigimod PH20 SC

Interventions

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Efgartigimod PH20 SC

Subcutaneous injection of efgartigimod PH20 SC

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No