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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called nipocalimab to see if it can help reduce the risk of a condition known as fetal and neonatal alloimmune thrombocytopenia (FNAIT) in pregnant women. FNAIT can occur when a mother's immune system attacks her baby's platelets, which are important for blood clotting. The trial is looking for women who have had at least one previous pregnancy affected by FNAIT and are currently pregnant with a baby that has a specific genetic makeup. Participants need to be in stable health and willing to avoid other clinical studies during the trial.

If you join this study, you will receive either nipocalimab or a placebo (a treatment that looks like the real drug but has no active ingredients) to see how effective it is in preventing FNAIT. The study is currently recruiting participants, so if you meet the eligibility criteria, you may have the opportunity to take part. It's important to discuss with your healthcare provider to understand more about the potential benefits and risks of participating in this trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
• • Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records
• • Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (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 (refer to the Investigator Brochure (IB))
• • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant