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A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

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Trial Profile

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Feb 2026

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At a glance

  • Drugs Nipocalimab (Primary)
  • Indications Anaemia; Fetal disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms AZALEA
  • Sponsors Janssen Research & Development

Most Recent Events

  • 13 Feb 2026 Planned End Date changed from 10 Jul 2029 to 30 Aug 2029.
  • 01 May 2025 Trial design published in the American Journal of Perinatology.
  • 01 May 2025 Trial design published in the American Journal of Perinatology.

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