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

Launched by ARGENX · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) adjust when switching from a treatment called intravenous immunoglobulin (IVIg) to a new medication called efgartigimod PH20 SC. The trial will last about 17 to 19 weeks. Researchers want to see if efgartigimod can be a safe and effective alternative for those who are currently receiving IVIg therapy.

To join the study, participants must be at least 18 years old and have a confirmed or suspected diagnosis of CIDP. They should also be receiving IVIg treatment regularly and at a stable dose for at least three doses. If participants are taking other medications, like corticosteroids or immunosuppressants, they need to be on a steady dose for a specified period. Anyone with other serious autoimmune diseases or different types of polyneuropathy won't be eligible. Throughout the trial, participants will receive careful monitoring and support as they transition to the new treatment.

Gender

ALL

Eligibility criteria

• 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