This study focuses on Hemolytic Disease of the Fetus and Newborn (HDFN), a condition where antibodies from the mother’s blood cross the placenta and attack the developing baby’s red blood cells. The research evaluates a new medication called nipocalimab, which is given through intravenous administration, comparing it to placebo. The purpose is to determine if nipocalimab can reduce the risk of fetal anemia in pregnancies where babies are at risk of developing severe HDFN.
The study involves pregnant women whose previous pregnancies were affected by severe HDFN, resulting in either the baby developing anemia, requiring blood transfusions before birth, or unfortunately losing the pregnancy. The medication or placebo will be given to participants during their pregnancy, with the treatment period lasting up to 23 weeks.
During the study, participants will receive either JNJ-80202135 (nipocalimab) as a solution for injection or infusion, or a saline solution. The study is designed so that neither the participants nor their doctors will know which treatment they are receiving. This helps ensure that the results are not influenced by expectations about the treatment.
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