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RECRUITING
NCT06533098
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-02-10

Completion Date

2029-12-05

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Nipocalimab

Nipocalimab will be administered intravenously.

DRUG

Intravenous immunoglobulins (IVIG)

IVIG will be administered intravenously.

DRUG

Prednisone

Prednisone will be administered orally.

Locations (22)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

UC Davis School of Medicine

Sacramento, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Advocate Children's Hospital

Park Ridge, Illinois, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

Medizinische Universitaet Graz

Graz, Austria

Medical University Vienna

Vienna, Austria

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitatsklinikum Jena

Jena, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Leiden University Medical Center

Leiden, Netherlands

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Instytut Matki i Dziecka

Warsaw, Poland

Panstwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, Poland

Birmingham Women's Hospital

Birmingham, United Kingdom

Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital

Liverpool, United Kingdom

Queen Charlotte's and Chelsea Hospital

London, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom