Fetal and Neonatal Alloimmune Thrombocytopenia: Nipocalimab Study

We are testing nipocalimab in pregnant individuals at risk of FNAIT to see if it can lower the chances of severe complications for the baby. This study compares the treatment to a placebo to evaluate its effectiveness.

>2 years>20 visitsConfirmation phase (III)Post-Trial Drug AccessCost ReimbursementPartially RemoteInvestigational MedicinesInjectionGynecology and ObstetricsInfectious Diseases

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Saline
Saline is a sterile saltwater solution used to hydrate patients, replace lost fluids, and rinse wounds or medical equipment.

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Sodium Chloride
Sodium chloride is a substance used to replace salts and fluids in the body and to clean or irrigate wounds and nasal passages.
Sodium Chloride Solution 0.9%
Sodium chloride 0.9% is a sterile salt solution used to replace fluids and electrolytes, hydrate patients, and clean wounds or body cavities.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Jnj-80202135
Nipocalimab

What similar medicines might you know?

Don't worry if you don't know the medicines tested in the trial. There is a chance you have heard about the similar medicines. Check the list below to see if you are familiar with any of them.

Acuolens
Addex Natriumklorid
Aminoplasmal E

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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UZ Leuven
Maternal-Fetal medicine
Heverlee, Belgium
Centre Hospitalier Universitaire De Lille
Gynecology-Obstetrics Department
Loos, France
Assistance Publique Hopitaux De Paris
Fetal Medecine Department
Saint-Mandé, France
Sponsor: Janssen - Cilag International
Last updated: Nov 26, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.