Study of Nipocalimab Given by IV to Adults With Chronic Inflammatory Demyelinating Polyneuropathy CIDP to Test Its Safety and Effectiveness in Preventing Relapse

What this Trial Is About

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. The study includes both Phase 2 and Phase 3 stages and aims to delay relapse in patients with CIDP who have shown clinical improvement from the treatment. Participants first receive an open-label loading dose of nipocalimab by intravenous infusion on Day 1, followed by infusions every two weeks from Week 2 to Week 12 Stage A. Those who respond and show clinical improvement move to Stage B, where they are randomly assigned to receive either nipocalimab or placebo infusions every two weeks for up to 52 weeks. After Stage B or if relapse occurs, participants may join an open-label extension phase receiving nipocalimab infusions every two weeks for up to two years or until commercial availability. During the study, participants undergo regular assessments including clinical evaluations, muscle strength tests, disability scales, and monitoring for adverse events. Researchers track time to relapse, changes in disability scores, muscle strength, grip strength, and laboratory values over the study periods. Safety is closely monitored through vital signs, laboratory tests, and adverse event reporting. The total participation can extend through the treatment phases and the long-term open-label extension as applicable.

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)