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

Launched by ARGENX · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called empasiprubart to see if it is safe and effective for adults with a condition called Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. CIDP is a nerve disorder that can cause weakness and numbness in the arms and legs. The study will first compare empasiprubart to a placebo (a treatment with no active medicine) for 6 months. After that, everyone in the study will receive empasiprubart for an additional 24 months to see how well it works over time.

Adults aged 18 to 74 who have been diagnosed with typical CIDP or certain types of CIDP, and who have ongoing symptoms or disabilities from the condition, may be eligible to join. People who have never been treated for CIDP or who are currently or previously treated with certain common therapies might also qualify. Participants will need to avoid other specific treatments and conditions to join. If accepted, participants can expect regular visits for treatment and check-ups over about two and a half years. This study is not yet recruiting, but it aims to help find better treatment options for people living with CIDP.

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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
• • Has residual disability and active disease
• • Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
• Exclusion Criteria:
• • Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
• • Sensory CIDP (including sensory-predominant CIDP)
• • Polyneuropathy of other causes
• • Clinical diagnosis of systemic lupus erythematosus (SLE)
• • Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation