NCT06533098From ClinicalTrials.govRecruiting

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 IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Thrombocytopenia, Neonatal Alloimmune

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 50
Started: 10 February 2025
Main results due: 15 December 2027
Study sites: 28
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 45 years.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(28)

The University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
UC Davis School of Medicine
Sacramento, California, United States
Recruiting
Childrens Hospital Colorado
Aurora, Colorado, United States
Recruiting
Advocate Children's Hospital
Park Ridge, Illinois, United States
Recruiting
Riley Children s Hospital
Indianapolis, Indiana, United States
Suspended
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
University of Texas Medical Branch
Galveston, Texas, United States
Recruiting
University of Utah
Salt Lake City, Utah, United States
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

Showing 28 of 28 sites. 27 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06533098. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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