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

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 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).

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.

Objective:  Nipocalimab is a neonatal fragment crystallizable (Fc) receptor (FcRn)-blocking monoclonal antibody that inhibits placental immunoglobulin G (IgG) transfer and lowers circulating maternal IgG levels. In an open-label, single-arm, phase 2 study, nipocalimab demonstrated evidence of safety and efficacy that support further investigation in a pivotal phase 3 trial of recurrent hemolytic disease of the fetus and newborn (HDFN). The phase 3 AZALEA study aims to evaluate the efficacy and safety of nipocalimab in a larger population at risk for severe HDFN, defined as HDFN associated with poor fetal outcomes or neonatal death.

Extracellular Acetylated Histone 3.3 Induces Inflammation and Lung Tissue Damage.

Extracellular histones, part of the protein group known as damage-associated molecular patterns (DAMPs), are released from damaged or dying cells and can instigate cellular toxicity. Within the context of chronic obstructive pulmonary disease (COPD), there is an observed abundance of extracellular histone H3.3, indicating potential pathogenic implications.