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)
Janssen Research & Development, LLC
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.
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13\^0/7 to Week 18\^6/7 at randomization * History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented: 1. fetal anemia as result of HDFN or fetal hydrops as result of HDFN or received greater than or equal to (\>=)1 IUT as a result of HDFN or 2. fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for Rhesus antigen D protein (RhD), Kell, Kell Rhesus antigen C protein (Rhc), Rhesus antigen E protein…
Interventions
- DrugNipocalimab
Nipocalimab will be administered as an intravenous infusion.
- DrugPlacebo
Placebo will be administered as an intravenous infusion.
Locations (61)
- University of California at San DiegoLa Jolla, California
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
- UC Davis School of MedicineSacramento, California
- Childrens Hospital ColoradoAurora, Colorado
- University of MiamiMiami, Florida
- Advocate Children's HospitalPark Ridge, Illinois