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NCT06533098PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

2/10/2025

Completion Date

12/11/2029

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).

Eligibility Criteria

Age Range: 18 years to 45 years

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

Interventions

DRUG

Nipocalimab

DRUG

Intravenous immunoglobulins (IVIG)

DRUG

Prednisone

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Conditions

Thrombocytopenia, Neonatal Alloimmune

Locations

The University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

UC Davis School of Medicine

Sacramento, California 95817

United States

Childrens Hospital Colorado

Aurora, Colorado 80045

United States

Advocate Children's Hospital

Park Ridge, Illinois 60068

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa 52242

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Texas Medical Branch

Galveston, Texas 77555

United States

University of Utah

Salt Lake City, Utah 84108

United States

Medizinische Universitaet Graz

Graz, 8036

Austria

Medical University Vienna

Vienna, 1090

Austria

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, 35392

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Universitatsklinikum Jena

Jena, 07747

Germany

Universitaetsklinikum Tuebingen

Tübingen, 72076

Germany

Leiden University Medical Center

Leiden, 2333 ZA

Netherlands

Instytut Centrum Zdrowia Matki Polki

Lodz, 93 338

Poland

Instytut Matki i Dziecka

Warsaw, 01 211

Poland

Panstwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, 02 507

Poland

Birmingham Women's Hospital

Birmingham, B15 2TG

United Kingdom

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

Liverpool, L8 7SS

United Kingdom

Queen Charlotte's and Chelsea Hospital

London, W12 0HS

United Kingdom

John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom