NCT06449651

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (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 evaluate the effectiveness of nipocalimab compared with placebo 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	Placebo	Placebo will be administered intravenously.

Timeline

• Start date: 2024-11-11
• Primary completion: 2029-12-05
• Completion: 2029-12-05
• First posted: 2024-06-10
• Last updated: 2026-04-13

Locations

21 sites across 12 countries: Belgium, Brazil, France, Hungary, Israel, Italy, Norway, Slovakia, Slovenia, Spain, Sweden, Switzerland

Regulatory

• FDA-regulated drug study