Back to search
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA)
Hemolytic Disease of the Fetus and Newborn
Clinicaltrials.gov:
EU CTIS:
#2022-502629-16-00
EudraCT:
J&J ID:
#CR109199
Other:
#80202135EBF3001
Interested in this trial?
Subscribe or share this trial
Trials at a glance
Status
Enrolling
Condition
Hemolytic Disease of the Fetus and Newborn
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Nipocalimab
Placebo
Age
18 to 45 years old
Biological sex
Female
Placebo?
Yes
Trial start date
December 20, 2023
Trial end date
October 8, 2029
CT.gov ID
#NCT05912517
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA)
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.
Primary outcome measures
- Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Secondary outcome measures
- Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
- Time to First Occurrence of IUT or Hydrops Fetalis
- Neonatal Mortality and Morbidity Index (NMMI) in Liveborn Neonates
- Number of IUT's Received During the Pregnancy
- Percentage of Pregnancies With Fetal Loss
- Percentage of Pregnancies With Fetal or Neonatal Death
- Percentage of Pregnancies With Hydrops Fetalis
- Percentage of Pregnancies Receiving IUT During Pregnancy
- Gestational Age (GA) at First IUT
- Percentage of Pregnancies Receiving >1 IUT During Pregnancy
- Percentage of Pregnancies Receiving IUT or HDFN Resulting in Fetal Demise (Less Than) <GA Week 20
- Gestational Age at Delivery
- Percentage of Pregnancies With Neonatal Death Through the Neonatal Period
- Percentage of Liveborn Neonates With HDFN-related Morbidities Other Than Anemia and Hyperbilirubinemia or Jaundice
- Absolute Weight of Liveborn Neonates or Infants
- Change From Baseline in Weight of Liveborn Neonates or Infants
- Liveborn Neonates Length of Stay in Neonatal Intensive Care Unit
- Percentage of Liveborn Neonates Receiving Exchange Transfusions for HDFN
- Number of Neonatal Exchange Transfusions per Liveborn Neonate
- Percentage of Liveborn Neonates or Infants with Simple Transfusions for HDFN
- Number of Simple Transfusions for HDFN per Liveborn Neonate or Infant
- Percentage of Liveborn Neonates With Hyperbilirubinemia Treated With Phototherapy
- Number of Days of Phototherapy Received for Hyperbilirubinemia per Liveborn Neonate
- Percentage of Liveborn Neonates or Infants Receiving Intravenous Immunoglobulin (IVIg) for HDFN Treatment
- Number of Maternal Deaths
- Number of Participants with Adverse Events (AEs)
- Number of Maternal Pregnancy Complications
- Number of IUT Related complications
- Percentage of Pregnancies With Cesarean Delivery, Preterm Birth, Fetal Growth, and Preeclampsia
- Percentage of Liveborn Neonates or Infants Who Died
- Percentage of Liveborn Neonates or Infants With AEs
- Percentage of Liveborn Neonates or Infants Receiving IVIg for Non-HDFN Indications
- Percentage of Liveborn Neonates or Infants With Abnormal Hearing
- Bayley Scales of Infant Development and Toddler Development
- Change From Baseline in Generalized Anxiety Disorder 7-Item (GAD7) Over time During Pregnancy and Postpartum
- Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
- Change From Baseline in EuroQol Five-dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
- Change From Baseline in EuroQol 5-Dimension Descriptive (EQ-5D) Index Score
- Infant Health-Related Quality of Life Instrument (IQI) Score for Neonate or Infant Overtime
Access detailed information on the trial:
Clinical trials information
© Johnson & Johnson and its affiliates 2026
