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

Phase 3 Recruiting 50 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2025-02-10
Primary completion: 2027-12-15
Completion: 2029-12-11

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	—	Intravenous
Subject	Nipocalimab	Monoclonal antibody	45 mg/kg	Intravenous
Background	Prednisone	Other / unclassified	—	Oral

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

Summary

Timeline

Publications

Drugs

Indications