At a glance
ClinicalIndex Comparison Record- ✓Pregnant with gestational age 13+0/7 to 18+6/7 weeks at randomization
- ✓History of severe HDFN in prior pregnancy (fetal anemia, hydrops, ≥1 IUT, or fetal loss/neonatal death)
- ✓Prior pregnancy alloantibody titers above critical levels (anti-Kell ≥4; others ≥16) with antigen-positive fetus
- ✓Current pregnancy maternal alloantibody (RhD, Kell, Rhc, RhE, RhC) with titers above critical level
- ✕Multiple gestation (twins or more)
- ✕Evidence of fetal anemia prior to randomization in current pregnancy
- ✕History of severe preeclampsia before GA 34 or severe fetal growth restriction in prior pregnancy
- ✕Current uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Nipocalimab and Placebo for Hemolytic Disease of the Fetus and Newborn. Currently recruiting, targeting 120 participants across 62 sites in 17 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
Participants will receive matching placebo IV qw from randomization through GA Week 35.
Interventions
Nipocalimab will be administered as an intravenous infusion.
Placebo will be administered as an intravenous infusion.