Trial intelligence / Profile preview

FREESIA-1: Nipocalimab in Reducing the Risk of FNAIT in At-risk Pregnancies

NCT06449651Phase 3Recruiting

Sponsor
Janssen Pharmaceutical
Start
Nov 2024
Primary completion
Dec 2029
Modality
Monoclonal Antibodies
Countries
12
01

Overview

Phase 3, randomised, double-blind trial in fetal and neonatal alloimmune thrombocytopenia (FNAIT) comparing Nipocalimab with Placebo (2 arms). Primary endpoint: Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L. Started Nov 2024; status: recruiting.

02

Drugs

nipocalimab
03

Conditions

fetal and neonatal alloimmune thrombocytopenia (FNAIT)

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