A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

Launched by ARGENX · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two treatments for adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves and can cause weakness and numbness. The study will look at how effective and safe a new medication called empasiprubart is compared to intravenous immunoglobulin (IVIg), which is a common treatment for CIDP. Participants will first take either empasiprubart or IVIg for 24 weeks, along with a placebo that looks like the other treatment. After this initial period, everyone will switch to empasiprubart for an additional 96 weeks.

To join the trial, participants must be diagnosed with CIDP and have responded to IVIg treatment in the past five years. They should also be currently receiving IVIg as part of their treatment and still have some ongoing symptoms. However, people with other autoimmune diseases or certain types of CIDP that are not being studied in this trial may not be eligible. Throughout the study, participants will have regular check-ups to monitor their health and response to the treatment. This trial offers an opportunity to help advance CIDP treatment options while also receiving care from medical professionals.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
• • Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
• • Has responded to IVIg in the past 5 years
• • Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
• • Has residual disability and active disease
• 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, including polyneuropathy of other causes
• • Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
• • Use of other long-acting immunomodulatory treatment