Clinical Trial

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Study acronym: AZALEA
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.
Protocol Amendment History 1 change
minor Completion pushed: 2029-07-10 -> 2029-10-08 2026-04-14
Trial Details
NCT Number NCT05912517
Lead Sponsor Janssen Research & Development, LLC
Conditions Hemolytic Disease of the Fetus and Newborn
Enrollment 120 participants
Start Date 2023-12-20
Primary Completion 2027-08-05 (estimated)
Study Completion 2029-10-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-06