A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Recruiting now · Phase 3
Conditions studied: Thrombocytopenia, Neonatal Alloimmune
In brief
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).
Key facts
- Study ID
- NCT06533098
- Run by
- Janssen Research & Development, LLC
- People needed
- 50
- Starts
- 2025-02-10
- Expected to finish
- 2029-12-11
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- UC Davis School of Medicine — Sacramento, California, United States (enrolling)
- Childrens Hospital Colorado — Aurora, Colorado, United States (enrolling)
- Advocate Children's Hospital — Park Ridge, Illinois, United States (enrolling)
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (enrolling)
- University of Rochester Medical Center — Rochester, New York, United States (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
- Oregon Health And Science University — Portland, Oregon, United States (enrolling)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
- Medizinische Universitaet Graz — Graz, Austria (enrolling)
- Medical University Vienna — Vienna, Austria (enrolling)
- Universitaetsklinikum Giessen und Marburg GmbH — Giessen, Germany (enrolling)
- Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
- Universitatsklinikum Jena — Jena, Germany (enrolling)
- Universitaetsklinikum Tuebingen — Tübingen, Germany (enrolling)
- Leiden University Medical Center — Leiden, Netherlands (enrolling)
- Instytut Centrum Zdrowia Matki Polki — Lodz, Poland (enrolling)
- Instytut Matki i Dziecka — Warsaw, Poland (enrolling)
- Panstwowy Instytut Medyczny MSWiA w Warszawie — Warsaw, Poland (enrolling)
- Birmingham Women's Hospital — Birmingham, United Kingdom (enrolling)
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital — Liverpool, United Kingdom (enrolling)
- Queen Charlotte's and Chelsea Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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