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Clinical Trials in the UK / NCT06533098
Recruiting Phase 3

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

NCT06533098 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-02-10
Last updated
2026-08-28

Condition(s) studied

Thrombocytopenia, Neonatal Alloimmune

Investigational drug(s) / intervention(s)

NipocalimabIntravenous immunoglobulins (IVIG)Prednisone

Nipocalimab: Nipocalimab will be administered intravenously.

Intravenous immunoglobulins (IVIG): IVIG will be administered intravenously.

Prednisone: Prednisone will be administered orally.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
The University of Alabama at Birmingham Birmingham Alabama Recruiting
UC Davis School of Medicine Sacramento California Recruiting
Childrens Hospital Colorado Aurora Colorado Recruiting
Advocate Children's Hospital Park Ridge Illinois Recruiting
Riley Children s Hospital Indianapolis Indiana Suspended
University of Iowa Hospital and Clinics Iowa City Iowa Recruiting
University of Rochester Medical Center Rochester New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Oregon Health And Science University Portland Oregon Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Texas Medical Branch Galveston Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Medizinische Universitaet Graz Graz Austria Recruiting
Medical University Vienna Vienna Austria Recruiting
Universitaetsklinikum Giessen und Marburg GmbH Giessen Germany Recruiting
Medizinische Hochschule Hannover Hanover Germany Recruiting
Universitatsklinikum Jena Jena Germany Recruiting
Universitaetsklinikum Tuebingen Tübingen Germany Recruiting
Sheba Medical Center Ramat Gan Israel Recruiting
Leiden University Medical Center Leiden Netherlands Recruiting
Instytut Centrum Zdrowia Matki Polki Lodz Poland Recruiting
Instytut Matki i Dziecka Warsaw Poland Recruiting
Panstwowy Instytut Medyczny MSWiA w Warszawie Warsaw Poland Recruiting
Birmingham Women's Hospital Birmingham United Kingdom Recruiting
Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital Liverpool United Kingdom Recruiting
Queen Charlotte's and Chelsea Hospital London United Kingdom Recruiting
John Radcliffe Hospital Oxford United Kingdom Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06533098 on ClinicalTrials.gov ↗ ← All trials in the UK