NCT06533098

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Thrombocytopenia, Neonatal Alloimmune

Interventions

Type	Name	Description
DRUG	Nipocalimab	Nipocalimab will be administered intravenously.
DRUG	Intravenous immunoglobulins (IVIG)	IVIG will be administered intravenously.
DRUG	Prednisone	Prednisone will be administered orally.

Timeline

• Start date: 2025-02-10
• Primary completion: 2027-12-15
• Completion: 2029-12-05
• First posted: 2024-08-01
• Last updated: 2026-04-13

Locations

24 sites across 6 countries: United States, Austria, Germany, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated drug study