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CC BY 4.0 · Am J Perinatol 2025; 42(07): 955-961
DOI: 10.1055/a-2529-4150
Short Communication

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

Yosuke Komatsu
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
Victor Olusajo
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
Leona E. Ling
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
Shumyla Saeed-Khawaja
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
May Lee Tjoa
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
Trishan Vaikunthanathan
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
Arpana Mirza
1   Janssen Pharmaceutical Companies of Johnson & Johnson, Cambridge, Massachusetts
,
Kenneth J. Moise  Jr.
2   Dell Medical School, The University of Texas at Austin, Austin, Texas
3   Comprehensive Fetal Care Center at Dell Children's Medical Center, Austin, Texas
› Author Affiliations Funding The AZALEA study is funded by Janssen Research & Development, LLC, a Johnson & Johnson Company. Medical writing support was provided by Panita Trenor, PhD, of Lumanity Communications Inc., and was funded by Janssen Global Services, LLC, a Johnson & Johnson Company.
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Comment on:

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 NewbornAm J Perinatol 2025; 42(07): 842-853
DOI: 10.1055/a-2404-8089

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

Supplementary Material



Publication History

Received: 03 January 2025

Accepted: 20 January 2025

Article published online:
06 March 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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