Status:
RECRUITING
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Thrombocytopenia, Neonatal Alloimmune
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06533098
Start Date
February 10 2025
End Date
December 5 2029
Last Update
December 5 2025
Active Locations (18)
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1
UC Davis School of Medicine
Sacramento, California, United States, 95817
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
University of Texas Medical Branch
Galveston, Texas, United States, 77555