A new clinical trial titled FREESIA-1 will seek to assess whether nipocalimab can prevent or delay the onset of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT) in at-risk pregnancies.
Study details were recently published in the American Journal of Perinatology, and the trial is sponsored by Johnson & Johnson.
Nipocalimab works by blocking the neonatal Fc receptor, a protein that helps transport maternal antibodies to the fetus to help build their immune systems. In patients with FNAIT, certain maternal antibodies called alloantibodies are produced that attack the fetus’ platelets, leading to thrombocytopenia. Therefore, blocking the activity of this receptor should, in theory, help to delay or prevent FNAIT.
A previous clinical trial found that nipocalimab may prevent fetal anemia in patients with severe hemolytic disease of the fetus and newborn (HDFN), a disease that shares several features with FNAIT. As a result, Johnson & Johnson decided to investigate its utility in FNAIT.
Eligible participants must be pregnant with a gestational age of 13 to 18 weeks and have a history of FNAIT in previous pregnancies. Additionally, the fetus must test positive for the HPA-1a antigen, and the mother must test positive for antibodies against HPA-1a.
Read more about FNAIT therapies
The study authors plan to recruit 39 participants from a number of maternal-fetal medicine centers throughout the world. Patients will receive either a placebo or nipocalimab weekly through an infusion into the vein.
Fetal health will be monitored every two weeks until delivery. Then, the newborns will undergo further testing to check for complications including intracranial hemorrhage, low platelet counts and bleeding. The study will also follow the children for a period of two years to evaluate development and quality of life.
“The outcomes of this study will contribute to further developing nipocalimab as a potential pharmacologic treatment option for reducing the risk of severe FNAIT, a rare disease with significant unmet medical need,” the authors wrote.
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