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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called nipocalimab to see if it can help reduce the risk of a serious condition known as fetal and neonatal alloimmune thrombocytopenia (FNAIT) during pregnancy. FNAIT occurs when a baby's platelets, which help with blood clotting, are low due to the mother's immune system reacting against the baby’s platelets. This study is specifically looking for pregnant women who are between 13 to 16 weeks along and have had at least one previous pregnancy affected by FNAIT. Participants should also have specific antibodies in their blood that indicate a risk for this condition.

If you qualify and choose to participate, you will receive either nipocalimab or a standard treatment called intravenous immunoglobulin (IVIG). Throughout the study, your health and the health of your baby will be closely monitored to ensure safety and effectiveness. This trial is currently recruiting participants, so if you’re interested or have further questions, it’s a good idea to talk to your healthcare provider about whether this study is right for you.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant and an estimated gestational age from week 13 to 18 at visit 1
• • Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\*10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
• • Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
• • Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
• • For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
• Exclusion Criteria:
• • Currently pregnant with multiple gestations (twins or more)
• • History of severe preeclampsia in a previous pregnancy
• • History of myocardial infarction, unstable ischemic heart disease, or stroke
• • Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone
• • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant