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

Thrombocytopenia, Neonatal Alloimmune
Clinicaltrials.gov:
EU CTIS:
#2023-509434-19-00
Other:
#80202135FNAIT3003
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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

Note: The criteria listed here are only a general guide. To join any trial, you must first have a medical check by a qualified doctor or healthcare professional. They will decide if the trial is a good fit and safe for your health.
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