Open-Label Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of FNAIT

Recruiting
18 years - 45 years
Female
Phase 3
1 participants needed
1 Location

Brief description of study

This is a global open-label, randomized, multicenter, interventional study in pregnant participants with a prior FNAIT-affected pregnancy to assess the efficacy, safety, tolerability, PK, PD, and immunogenicity of nipocalimab or IVIG.The study will target participants whose current pregnancies are affected by HPA-1a and/or HPA-5b incompatibility.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pregnant
  • Age: 18 years - 45 years
  • Gender: Female

Inclusion Criteria:

  • Pregnant and an estimated gestational age (GA) from week 13* to 18 at visit 1

    *Randomization for high-risk FNAIT participants to occur at GA Week 12

  • 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

Updated on 09 Jun 2026. Study ID: 25-0792

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