RecruitingPhase 3NCT06449651

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Sponsor

Janssen Research & Development, LLC

Enrollment

39 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Thrombocytopenia, Neonatal Alloimmune

Summary

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nipocalimab and a drug called Placebo for people with thrombocytopenia, neonatal alloimmune. The study is currently recruiting participants at 21 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNipocalimab

Nipocalimab will be administered intravenously.

DRUGPlacebo

Placebo will be administered intravenously.

Locations(21)

Universitair Ziekenhuis Leuven

Leuven, Belgium

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, Brazil

CHRU Lille

Lille, France

Hopital trousseau- APHP

Paris, France

Semmelweis Egyetem

Budapest, Hungary

Sheba Medical Center

Ramat Gan, Israel

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Rome, Italy

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital HF Ulleval sykehus

Oslo, Norway

Universitetssykehuset Nord-Norge HF

Tromsø, Norway

St. Olavs Hospital

Trondheim, Norway

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Univerzitná nemocnica Martin

Martin, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, Slovakia

Univerzitetni klinicni center Ljubljana

Ljubljana, Slovenia

Hosp. Virgen Del Rocio

Seville, Spain

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06449651

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