Phase 3 Study Comparing Empasiprubart and IVIg Treatments in Adults With Chronic Inflammatory Demyelinating Polyneuropathy CIDP

What this Trial Is About

This trial investigates the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. It compares the effects of empasiprubart and intravenous immunoglobulin IVIg to evaluate which treatment may better reduce symptoms and improve function in people with CIDP. The study is a Phase 3, randomized, double-blind trial designed to assess both efficacy and safety of these treatments over an extended period. Participants are randomly assigned in Part A to receive either empasiprubart with a placebo resembling IVIg or IVIg with a placebo resembling empasiprubart for 24 weeks 6 months. After Part A, all participants enter Part B, where they receive empasiprubart for an additional 96 weeks 24 months. During Part B, those previously receiving empasiprubart continue with it, and those initially on IVIg switch to empasiprubart. Treatments are administered by intravenous infusion using a double-dummy design to maintain blinding. Throughout the study, participants undergo regular assessments of their disability, strength, grip, and quality of life using various scales such as aINCAT, I-RODS, MRC-SS, and others. Safety is monitored by tracking adverse events and antibody formation against empasiprubart. The primary outcome is the reduction of at least one point in the aINCAT score at week 24. Total participation lasts up to 120 weeks, including both treatment periods, with ongoing evaluations to understand the long-term effects of empasiprubart.

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