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CC BY 4.0 · Am J Perinatol
DOI: 10.1055/a-2761-1775
Short Communication

Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia

Authors

  • Pamela Baker

    1   Johnson & Johnson, Spring House, Pennsylvania, United States

  • Babajide Keshinro

    2   Johnson & Johnson Biologics BV, Leiden, The Netherlands

  • Barbara Stegmann

    1   Johnson & Johnson, Spring House, Pennsylvania, United States

  • Abbie Oey

    1   Johnson & Johnson, Spring House, Pennsylvania, United States

  • Cathye Shu

    1   Johnson & Johnson, Spring House, Pennsylvania, United States

  • Dirk Heerwegh

    3   Johnson & Johnson, Beerse, Belgium

  • Rebecca Zaha

    1   Johnson & Johnson, Spring House, Pennsylvania, United States

  • Hillary Van Valkenburgh

    1   Johnson & Johnson, Spring House, Pennsylvania, United States

Funding Information These studies are sponsored by Johnson & Johnson. Medical writing support was provided by Anna Douyon, PhD, of Lumanity Communications Inc., and funded by Johnson & Johnson.
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Abstract

This article is a plain language summary of publication (PLSP) of the following articles: “Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-1)” by Tiller et al published in American Journal of Perinatology on July 28, 2025 (doi:10.1055/a-2666-5642) and “Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-3)” by Bussel et al published in American Journal of Perinatology on November 25, 2025 (doi: 10.1055/a-2753-9323). This PLSP describes the design of the phase 3, placebo-controlled FREESIA-1 and open-label FREESIA-3 trials, which will help researchers understand if nipocalimab, an investigational treatment, can be used to safely treat pregnant individuals who are at risk for fetal and neonatal alloimmune thrombocytopenia (FNAIT). This PLSP will help the general public, including those affected by FNAIT, and health care professionals understand the two studies. It provides information on the eligibility criteria, study design, treatments, and outcomes of interest. An infographic summary of this article is available in the [Supplementary Material] (available in the online version only).

Keywords

FNAIT - study design - efficacy - safety - nipocalimab

Supplementary Material



Publication History

Received: 12 November 2025

Accepted: 02 December 2025

Article published online:
29 December 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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  • References

  • 1 Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a phase 3, multicenter, randomized, placebo-controlled, double-blind study of nipocalimab in pregnancies at risk for fetal and neonatal alloimmune thrombocytopenia. 2025; Am J Perinatol (e-Pub ahead of print).
    Thieme ConnectPubMedSearch in Google Scholar
  • 2 Bussel J, Stegmann B, Baker P. et al. Design of a phase 3, multicenter, randomized, open-label study of nipocalimab or IVIG and prednisone in pregnancies at risk for fetal and neonatal alloimmune thrombocytopenia. 2025; Am J Perinatol (e-Pub ahead of print).
    Thieme ConnectPubMedSearch in Google Scholar