AZALEA: Nipocalimab in Hemolytic Disease of the Fetus and Newborn
Research type
Research Study
Full 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).
IRAS ID
1008016
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2022-502629-16
ISRCTN Number
ISRCTN12057804
Clinicaltrials.gov Identifier
Research summary
Hemolytic disease of the newborn and fetus (HDFN) is a rare and potentially life-threatening blood disorder in newborn babies and fetuses that occurs when the blood types of the pregnant individual and fetus/baby are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby. This may lead to anemia (low hemoglobin levels), jaundice (yellow discoloration of the skin because of the high levels of the chemical, bilirubin in blood) and other related complications.
Currently, severe HDFN is most commonly treated by injecting donor red blood cells into the fetus, a procedure called intrauterine transfusion. Nipocalimab, the study drug in this trial, is a protein that targets and binds to a specific molecule called FcRn (neonatal fragment crystallizable receptor). These receptors are found throughout the body and also in the placenta.
In pregnant individuals at risk for severe HDFN, nipocalimab aims to decrease the level of IgG (immunoglobulin G) antibodies* targeting fetal RBCs by binding to the FcRn receptor thereby decreasing IgG levels in the pregnant individual pregnant individuals IgG antibodies to the fetus across the placenta. Nipocalimab may be a less invasive option for managing severe HDFN. (*one type of protein that protects the body from infections caused by bacteria, viruses, and other foreign substances in the blood.)
The purpose of the study is to assess the safety and effectiveness of nipocalimab compared to placebo (a drug like substance that has no therapeutic effect) in the treatment of pregnant individuals at risk of developing severe HDFN. Not everyone in the study will receive nipocalimab. For every two participants who receive nipocalimab, one participant receives placebo. This is a double-blind study, which means that the participant and the study doctor/team will not know whether if you are receiving nipocalimab or placebo.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0223
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion