Parkwood

Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab. This Phase 2/3 study focuses on delaying disease relapse in this patient group, based on diagnosis criteria from the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021. Participants are adults diagnosed with progressing or relapsing forms of CIDP and with active disease as indicated by specific disability scores. Participants will receive either nipocalimab or a placebo, both administered intravenously. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple stages, including a withdrawal phase to observe the time to first relapse over up to 52 weeks. Nipocalimab dosing details and treatment schedules are managed to compare its effects against placebo in maintaining disease control. During the study, participants will undergo regular assessments to monitor their condition and response to treatment. Researchers will track the time until a relapse event occurs, alongside safety monitoring. Eligibility is confirmed by disability scoring and disease activity evaluations. The study includes ongoing evaluation of participant health and safety, ensuring comprehensive data collection over the treatment and observation periods.