Trial intelligence / Profile preview

FREESIA-3: Nipocalimab or IVIG in Pregnancies At Risk of FNAIT

NCT06533098Phase 3Recruiting

Sponsor
Janssen Pharmaceutical
Start
Feb 2025
Primary completion
Dec 2027
Modality
Monoclonal Antibodies
Countries
11
01

Overview

Phase 3, randomised, open-label trial of nipocalimab in fetal and neonatal alloimmune thrombocytopenia (FNAIT) (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L. Started Feb 2025; status: recruiting.

02

Drugs

nipocalimab
03

Conditions

fetal and neonatal alloimmune thrombocytopenia (FNAIT)

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