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Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Trial Profile

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 May 2025

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At a glance

  • Drugs Nipocalimab (Primary)
  • Indications Neonatal alloimmune thrombocytopenia
  • Focus Registrational; Therapeutic Use
  • Acronyms FNAIT; FREESIA-1
  • Sponsors Janssen Research & Development

Most Recent Events

  • 19 Nov 2024 According to a Johnson & Johnson media release, an overview of an ongoing Phase 3 FNAIT clinical study design will be presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego from December 7-10.
  • 01 Oct 2024 Planned initiation date changed from 23 Sep 2024 to 1 Oct 2024.
  • 12 Sep 2024 Planned initiation date changed from 22 Jul 2024 to 23 Sep 2024.

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