Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia in At-risk Pregnancies

What this Trial Is About

Researchers are evaluating nipocalimab compared with a placebo to see if it can reduce the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT) in pregnant women at risk. This randomized, double-blind, placebo-controlled Phase 3 study focuses on pregnancies affected by FNAIT, a condition where the mother's immune system attacks fetal platelets, leading to low platelet counts and bleeding risks. Pregnant participants will be randomly assigned to receive either nipocalimab or a placebo, both administered intravenously. The study includes maternal dosing during pregnancy, with treatments given between gestational weeks 13 to 18. The trial monitors mothers and their babies closely throughout pregnancy and after birth to assess safety and effects. Participants will undergo health assessments including physical exams, medical histories, vital signs, ECGs, and laboratory tests. Researchers will measure outcomes such as fetal and neonatal death, severe bleeding, platelet counts at birth and during the first week post-birth, and the need for platelet transfusions. Safety monitoring for both mothers and infants continues up to 104 weeks after birth, including evaluation of infant development and maternal antibody responses to nipocalimab.

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