Double-blind Phase 3 Study of Nipocalimab to Reduce Risk of Fetal and Neonatal Alloimmune Thrombocytopenia in Pregnant Women

What this Trial Is About

Researchers are studying nipocalimab to see if it can reduce the risk of severe fetal and neonatal alloimmune thrombocytopenia FNAIT compared to a placebo. This condition affects newborns and can lead to low platelet counts and serious bleeding. The trial is designed as a double-blind, randomized, placebo-controlled study focusing on pregnant women at risk of FNAIT. Participants will be randomly assigned to receive either nipocalimab or a placebo through intravenous infusions. The study includes pregnant women between 13 and 18 weeks of gestation who have a history of FNAIT in prior pregnancies and meet specific antibody and fetal genotype criteria. Treatment will continue with monitoring up to 24 weeks postpartum, with safety and effectiveness closely evaluated. During the study, participants and their babies will undergo various assessments including blood platelet counts at birth, bleeding events monitoring, and developmental evaluations up to 104 weeks. Maternal health will be monitored through physical exams, laboratory tests, and ECGs. Researchers will track adverse events and antibody responses to nipocalimab, aiming to understand its impact on reducing risks associated with FNAIT while ensuring maternal and infant safety.

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)