Plain Language Summary of Publication: Design of the Phase 3 AZALEA Trial of Nipocalimab in Severe Hemolytic Disease of the Fetus and Newborn

Abstract

This article is a plain language summary of publication (PLSP) of the following article: Design of a phase 3, global, multicenter, randomized, placebo-controlled, double-blind study of nipocalimab in pregnancies at risk for severe hemolytic disease of the fetus and newborn by Komatsu et al published in American Journal of Perinatology on September 17, 2024 (doi:10.1055/a-2404-8089). This PLSP describes the design of the phase 3 AZALEA clinical trial in pregnant participants at risk for developing severe hemolytic disease of the fetus and newborn (HDFN). In this study, researchers will determine if an investigational treatment called nipocalimab can be used safely and effectively to treat pregnant individuals who are at risk for severe HDFN. This PLSP will help members of the public, including individuals and families affected by HDFN, understand the study. It may also be helpful for health care professionals. An infographic summary of this article is available in the [Supplementary Material].

Key Points

• Severe HDFN causes serious health issues for babies

• IUTs carry risks of complications and fetal loss

• Nipocalimab reduces fetal anemia and IUTs in HDFN

• AZALEA is testing nipocalimab for severe HDFN

Keywords

neonatal Fc receptor blocker - nipocalimab - HDFN - intrauterine transfusion - red blood cell alloimmunization - safety - efficacy - study design