clinical trial · NCT05912517
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Janssen Research & Development, LLC·phase3·recruiting·n = 120
Hemolytic Disease of the Fetus and NewbornNipocalimabPlacebo
brief summary
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.
started
Dec 20, 2023
primary completion
Aug 5, 2027
completion
Oct 8, 2029
last updated
Jun 5, 2026
official title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol