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

RECRUITINGPHASE3

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)

NCT06533098•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).

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Pregnant and an estimated gestational age from week 13 to 18 at visit 1
•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

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

Key Dates

Start Date

February 10, 2025

Primary Completion Date

December 15, 2027

Completion Date

December 5, 2029

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Thrombocytopenia, Neonatal Alloimmune

Interventions

Nipocalimab

DRUG

Intravenous immunoglobulins (IVIG)

DRUG

Prednisone

DRUG

Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com