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

ClinicalTrials.gov ID: NCT06533098

Public ClinicalTrials.gov record NCT06533098. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 18, 2026, 1:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID: NCT06533098
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 50 participants

Conditions and interventions

Conditions

Thrombocytopenia, Neonatal Alloimmune

Interventions

Intravenous immunoglobulins (IVIG) Drug
Nipocalimab Drug
Prednisone Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 9, 2025
Primary completion: Dec 14, 2027
Completion: Dec 4, 2029
Last update posted: May 7, 2026

2025 – 2029

United States locations

U.S. sites: 10
U.S. states: 10
U.S. cities: 10

Facility	City	State	ZIP	Site status
The University of Alabama at Birmingham	Birmingham	Alabama	35205	Recruiting
UC Davis School of Medicine	Sacramento	California	95817	Recruiting
Childrens Hospital Colorado	Aurora	Colorado	80045	Recruiting
Advocate Children's Hospital	Park Ridge	Illinois	60068	Recruiting
University of Iowa Hospital and Clinics	Iowa City	Iowa	52242	Recruiting
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Recruiting
University of Cincinnati	Cincinnati	Ohio	45267	Recruiting
Oregon Health And Science University	Portland	Oregon	97239	Recruiting
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Recruiting
University of Texas Medical Branch	Galveston	Texas	77555	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06533098, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 7, 2026 · Synced May 18, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06533098 live on ClinicalTrials.gov.

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