For families facing a pregnancy complicated by rare alloimmune conditions, access to specialized care and innovative research can make all the difference. The University of Texas Medical Branch (UTMB) is helping lead that effort as an active study site for two important Phase 3 clinical trials evaluating nipocalimab, an investigational therapy designed to improve outcomes for pregnancies affected by rare maternal-fetal conditions.
UTMB is currently enrolling eligible patients into the Phase 3 AZALEA study for Hemolytic Disease of the Fetus and Newborn (HDFN) and the Phase 3 FREESIA-3 study for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). Both studies are sponsored by Johnson & Johnson Innovative Medicine and are evaluating nipocalimab, an investigational monoclonal antibody designed to reduce the transfer of harmful maternal antibodies across the placenta.
The studies are led by Sonia Robazetti, MD, Assistant Director of the Research Support Unit, Luis Pacheco, MD, Division Chief of Obstetrics and Maternal-Fetal Medicine, and Sangeeta Jain, MD, Director of MFM Ultrasound. Together, they are committed to expanding access to innovative clinical research while providing exceptional care for families facing high-risk pregnancies.
Specialized Care for the Highest-Risk Pregnancies
Patients participating in either study receive care through UTMB’s Level IV Maternal-Fetal Medicine Unit, where specialists care for some of the most medically complex pregnancies. The unit provides comprehensive, multidisciplinary care with 24/7 access to maternal-fetal medicine specialists and advanced support services, ensuring patients receive expert care throughout every stage of pregnancy.
By combining advanced clinical care with leading-edge research, UTMB offers hope to families navigating rare pregnancy complications.
AZALEA Study: Research for Pregnancies at Risk for Severe HDFN
Hemolytic Disease of the Fetus and Newborn (HDFN) occurs when a pregnant person’s immune system produces antibodies that attack a baby’s red blood cells. This immune response, known as maternal alloimmunization, most commonly develops following a previous pregnancy or blood transfusion. While HDFN rarely affects a first pregnancy, it can become increasingly severe in subsequent pregnancies once these antibodies have formed.
The Phase 3 AZALEA trial is evaluating nipocalimab in women who are at risk for severe HDFN because of a previously affected pregnancy.
Women may be eligible to participate if they:
- Are between 18 and 45 years of age
- Have tested positive for red blood cell antibodies
- Have experienced HDFN in a previous pregnancy
Researchers hope this study will determine whether nipocalimab can reduce the effects of maternal antibodies on the fetus and improve pregnancy outcomes for families affected by HDFN.
FREESIA-3 Study: Advancing Research for FNAIT
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is a rare pregnancy disorder in which maternal antibodies attack the baby’s platelets. Because platelets are essential for normal blood clotting, affected babies can experience complications ranging from low platelet counts to severe, potentially life-threatening bleeding before or shortly after birth.
The Phase 3 FREESIA-3 study is evaluating nipocalimab as a potential treatment for pregnancies at risk for FNAIT.
Eligible participants receive:
- Study medication and study-related care at no cost
- Comprehensive evaluations of both maternal and fetal health throughout the study
- Close monitoring by UTMB’s experienced maternal-fetal medicine and research teams
By participating, families not only gain access to specialized care but also contribute to research that may improve future treatment options for pregnancies affected by FNAIT.
Advancing the Future of Maternal-Fetal Care
Clinical research plays a vital role in advancing treatment options for rare pregnancy complications. Through participation in the AZALEA and FREESIA-3 trials, the University of Texas Medical Branch is helping shape the future of maternal-fetal medicine while providing compassionate, expert care to families facing some of pregnancy’s most complex challenges.
If you have experienced HDFN or FNAIT in a previous pregnancy and are planning or currently experiencing another pregnancy, you may be eligible to participate in one of these important clinical trials. Talk with your maternal-fetal medicine specialist or contact the UTMB research team at obgynrsu@utmb.edu to learn more about eligibility and enrollment.
About the Studies
AZALEA and FREESIA-3 are global Phase 3 clinical trials sponsored by Johnson & Johnson Innovative Medicine to evaluate the safety and efficacy of the investigational therapy nipocalimab. Participation is voluntary, and eligibility requirements apply.
