A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Feta
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).
| Condition(s) | Thrombocytopenia, Neonatal Alloimmune |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | 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 ex |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Lead sponsor | Janssen Research & Development, LLC |
| Locations | 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 (+20 more sites) |
| Start date | 2025-02-10 |
| NCT ID | NCT06533098 |
| Official listing | https://clinicaltrials.gov/study/NCT06533098 |