Phase 3 Study Comparing Riliprubart and Intravenous Immunoglobulin IVIg in Adults With Chronic Inflammatory Demyelinating Polyneuropathy CIDP

What this Trial Is About

Researchers are studying the effectiveness of riliprubart compared to intravenous immunoglobulin IVIg in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP who are already receiving IVIg maintenance treatment. This Phase 3 trial aims to evaluate how well riliprubart works and its safety over a study period lasting up to 109 weeks, including screening, treatment, and follow-up phases. Participants are randomly assigned to one of two groups one receives riliprubart along with a placebo IVIg infusion for 24 weeks, followed by a 24-week open-label extension phase where all receive riliprubart the other group continues IVIg treatment with a placebo riliprubart for 24 weeks, then also enters the open-label extension phase receiving riliprubart. The study uses intravenous and subcutaneous solutions for administration and includes a double-blind design to compare treatments fairly. During the study, participants undergo various assessments including disability scales, grip strength measurements, fatigue scales, and health quality evaluations from baseline up to week 48 and beyond. Researchers will monitor treatment responses, relapses, adverse events, and immune responses throughout the trial. Participants are followed closely for safety and effectiveness until the study concludes, with total involvement lasting up to 109 weeks.

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)