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Recruiting NCT06533098

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

Phase III Interventional Thrombocytopenia, Neonatal Alloimmune

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nipocalimab, Intravenous immunoglobulins (IVIG), Prednisone.
Who it may be relevant to
Registry conditions: Thrombocytopenia, Neonatal Alloimmune. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Germany, Netherlands, Poland +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Overview

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).

Interventions

  • Drug Nipocalimab
    Nipocalimab will be administered intravenously.
  • Drug Intravenous immunoglobulins (IVIG)
    IVIG will be administered intravenously.
  • Drug Prednisone
    Prednisone will be administered orally.

Primary outcome measures

  • Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L [Time frame: Up to 1 Week post birth]
Secondary outcome measures (12)
  • Platelet Count at Birth in a Neonate [Time frame: At birth]
  • Neonate/Fetus with Outcome of Death [Time frame: Up to 1 Week post birth]
  • Neonate with Platelet Count at Birth <10*10^9/L [Time frame: At birth]
  • Neonate with Platelet Count at Birth <30*10^9/L [Time frame: At birth]
  • Neonate with Platelet Count at Birth <50*10^9/L [Time frame: At birth]
  • Neonate with Platelet Count at Birth <150*10^9/L [Time frame: At birth]
  • Nadir Platelet Count in a Neonate [Time frame: Up to 1 Week post birth]
  • Neonate Requiring Platelet Transfusion [Time frame: Up to 1 Week post birth]
  • Number of Platelet Transfusions in Neonate [Time frame: Up to 1 Week post birth]
  • Number of Donor Exposures for Platelet Transfusions in Neonate [Time frame: Up to 1 Week post birth]
  • Neonate/Fetus With Adjudicated Bleeding [Time frame: Up to 1 Week post birth]
  • Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia [Time frame: Up to 1 Week post birth]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • The University of Alabama at Birmingham — Birmingham
  • UC Davis School of Medicine — Sacramento
  • Childrens Hospital Colorado — Aurora
  • Advocate Children's Hospital — Park Ridge
  • University of Iowa Hospital and Clinics — Iowa City
  • University of Rochester Medical Center — Rochester
  • University of North Carolina at Chapel Hill — Chapel Hill
  • University of Cincinnati — Cincinnati
  • … and 4 more centers
Germany · 4 centers
  • Universitaetsklinikum Giessen und Marburg GmbH — Giessen
  • Medizinische Hochschule Hannover — Hanover
  • Universitatsklinikum Jena — Jena
  • Universitaetsklinikum Tuebingen — Tübingen
United Kingdom · 4 centers
  • Birmingham Women's Hospital — Birmingham
  • Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital — Liverpool
  • Queen Charlotte's and Chelsea Hospital — London
  • John Radcliffe Hospital — Oxford
Poland · 3 centers
  • Instytut Centrum Zdrowia Matki Polki — Lodz
  • Instytut Matki i Dziecka — Warsaw
  • Panstwowy Instytut Medyczny MSWiA w Warszawie — Warsaw
Austria · 2 centers
  • Medizinische Universitaet Graz — Graz
  • Medical University Vienna — Vienna
Netherlands · 1 center
  • Leiden University Medical Center — Leiden

Publications

  • Bussel J, Stegmann B, Baker P, Oey A, Jiang Y, Zaha R, Van Valkenburgh H, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(10):1335-1344. doi: 10.1055/a-2753-9323. Epub 2025 Nov 25. PMID 41290206

Identifiers

NCT: NCT06533098 · 80202135FNAIT3003 · 2023-509434-19-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗