Yaizu

Researchers are evaluating the effectiveness of riliprubart compared to a placebo in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) whose disease has not responded to standard treatments. This is a Phase 3, double-blind, placebo-controlled study focusing on participants with refractory CIDP, including typical and variant forms such as motor CIDP and multifocal CIDP. The study aims to assess response rates over time to better understand the potential benefits and safety of riliprubart for this condition. Participants will receive either riliprubart or placebo administered as a solution via intravenous infusion or subcutaneous injection. The treatment period includes multiple phases with dosing and monitoring planned through 48 weeks. The study includes a screening phase, treatment phases, and follow-up extending up to a total of 111 weeks. Both groups will be monitored for lasting treatment responses, with specific attention to changes from baseline to weeks 24 and 48. During the study, participants will undergo regular assessments to track their disease activity and response to treatment. Evaluations include clinical scoring using the INCAT and CIDP disease activity scores, documentation of vaccinations, and monitoring for adverse effects. Researchers will measure the percentage of participants showing a treatment response and those maintaining that response over time, while also ensuring participant safety through ongoing follow-up and clinical evaluations throughout the study duration.

Researchers are evaluating the effectiveness of riliprubart compared to the usual treatment of intravenous immunoglobulin (IVIg) in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who are already receiving maintenance IVIg treatment. This Phase 3 study aims to assess how well riliprubart works and its safety in this population. Participants must meet specific CIDP diagnostic criteria and have a history of responding to IVIg treatment. The study involves administering riliprubart or placebo through intravenous (IV) or subcutaneous (SC) solutions, alongside the usual IVIg treatment. The treatment phase includes a randomized, double-blind comparison of riliprubart versus IVIg, followed by an open-label extension period for continued evaluation. The entire study lasts up to 109 weeks, encompassing screening, treatment, and follow-up phases. Participants will have regular assessments to monitor their response to treatment, including measurements of disability and disease activity scores. Researchers will track the percentage of participants showing a response from baseline to week 24 and those maintaining response through week 48 during the extension. Safety and long-term effects will also be observed throughout the study duration, ensuring comprehensive monitoring of participant health and treatment outcomes.