UK researchers enrolling patients in trial to address rare pregnancy condition
LEXINGTON, Ky. (Sept. 30, 2025) — Researchers at UK HealthCare are now enrolling patients in the phase 3 AZALEA trial to evaluate the safety and efficacy of an investigational medication in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). This study is the first of its kind to include pregnant individuals at risk for severe HDFN, a serious condition that can cause life-threatening anemia in the fetus or newborn.
HDFN is a rare but potentially life-threatening condition that affects up to 80 of every 100,000 pregnancies each year. Caused by incompatibility between the pregnant person’s and fetus’ blood groups, HDFN can lead the maternal immune system to attack fetal red blood cells, resulting in anemia, jaundice or edema. In severe cases, it may cause life-threatening complications requiring invasive interventions. HDFN usually develops in later pregnancies, after antibodies have formed during an earlier pregnancy.
UK HealthCare is among the maternal fetal specialty centers identified in the U.S. to enroll patients from this at-risk population. Once HDFN has been diagnosed, the current standard of care can include repeated invasive medical interventions such as intrauterine transfusions (IUTs) that carry a risk of preterm birth and fetal death. There are currently no approved therapeutics that may prevent HDFN from occurring in pregnant individuals whose immune systems produced antibodies during previous pregnancies.
“Investigational medications for HDFN may one day address a pressing need in high-risk obstetrics as affected patients and their families often struggle with the physical and emotional toll of repeated invasive medical interventions like fetal blood transfusions, which have risks,” said Emily DeFranco, D.O., chair of the Department of Obstetrics and Gynecology at UK HealthCare. “We are proud to play a role in working towards a treatment for this rare disease, that may impact both a pregnant individual and their fetus or newborn.”
Pregnant individuals ages 18-45 years who have experienced severe HDFN in a prior pregnancy may be eligible to enroll in the study. All participants in this study sponsored by Janssen Research & Development LLC., a Johnson & Johnson company will receive trial-required medication and trial-required medical care at no cost. Participants will also be reimbursed for trial-required travel and expenses.
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