Study Comparing Nipocalimab and IVIG Treatments in Pregnant Women at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia

What this Trial Is About

Researchers are evaluating the efficacy and safety of nipocalimab compared to intravenous immunoglobulin IVIG in pregnant women at risk of fetal and neonatal alloimmune thrombocytopenia FNAIT, a condition where maternal antibodies attack fetal platelets. This Phase 3 trial aims to reduce the risk of severe bleeding or low platelet counts in affected fetuses and newborns. The study is sponsored by Janssen Research & Development, LLC and focuses on pregnancies complicated by specific maternal alloantibodies and fetal genotypes. Participants are randomly assigned to receive either nipocalimab or IVIG treatments during pregnancy. Nipocalimab is given intravenously starting between 13 to 18 weeks of gestation until delivery. Those receiving IVIG start at gestational week 12 for high-risk pregnancies or week 20 for standard-risk pregnancies, with oral prednisone added per protocol and tapered off after delivery based on tolerance and investigator judgment. Both treatments are studied for their impact on fetal and neonatal outcomes. During the study, participants undergo assessments including physical exams, vital signs, ECGs, and laboratory tests to monitor health and response. Researchers will track outcomes such as fetal or neonatal death, severe bleeding, and platelet counts up to one week after birth. Long-term follow-up includes developmental assessments at 52 and 104 weeks and monitoring for treatment-emergent adverse events in mothers and infants. The overall participation period extends through delivery and includes postnatal evaluations for both mother and child.

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)