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

NCT06533098

RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Thrombocytopenia, Neonatal Alloimmune

Interventions: Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone

Countries: United States, Austria, Germany, Netherlands, Poland, United Kingdom

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (26)
  • Birmingham, Alabama, United States
  • Sacramento, California, United States
  • Aurora, Colorado, United States
  • Park Ridge, Illinois, United States
  • Iowa City, Iowa, United States
  • Rochester, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Galveston, Texas, United States
  • Salt Lake City, Utah, United States
  • Graz, Austria
  • Vienna, Austria
  • Giessen, Germany
  • Hanover, Germany
  • Jena, Germany
  • Tübingen, Germany
  • Leiden, Netherlands
  • Lodz, Poland
  • Warsaw, Poland
  • Warsaw, Poland
  • Birmingham, United Kingdom
  • Liverpool, United Kingdom
  • London, United Kingdom
  • Oxford, United Kingdom