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OpenTrials
Completed

NCT Number: NCT06637072

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

efgartigimod PH20 SC

Biological

Subcutaneous injection of efgartigimod PH20 SC

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

    Time frame: Up to 12 weeks

Secondary outcomes

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

    Time frame: Up to 12 weeks

  2. Changes from baseline in TSQM-9 scores over time

    Time frame: Up to 12 weeks

  3. Changes from baseline in PGI-C scores over time

    Time frame: Up to 12 weeks

  4. Changes from baseline in PGI-S scores over time

    Time frame: Up to 12 weeks

  5. Incidence of (S)AEs

    Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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