Clinical Trials
The Society supports its members and other clinicians in the field by promoting various research activities. SMFM does not conduct or endorse the studies or trials below.
If you are interested in posting, please review our clinical trials and studies process guidelines for more information. SMFM charges an administrative fee to post and distribute these studies and clinical trials.
A Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopeniaposted December 9, 2025
FREESIA-3 is an open-label global multicenter randomized research study of an investigational FcRn inhibitor called nipocalimab or Intravenous Immunoglobulin (IVIG) in pregnant adults at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). The safety and efficacy profile of this investigational medicine in this patient population has not been established. FNAIT is a rare condition marked by low platelet counts in the fetus or newborn, resulting from incompatibility between maternal and fetal human platelet antigens (HPA). In this study, participants will be monitored rigorously: mothers will be observed for up to 6 months postpartum, while infants will be followed for a period of 2 years.
Participants will be asked to
- Visit the site weekly during pregnancy and a few times postpartum.
Eligibility
- Pregnant individuals aged 18 to 45 years at gestational age week 130/7 to 186/7
- A prior pregnancy affected by FNAIT
- Generally healthy with a singleton pregnancy
Early referral of potential participants to study sites is recommended to ensure screening and enrollment within the study timelines. Please visit our website if you’d like to learn more and to refer a patient to your closest FREESIA-3 study site in the US.
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newbornposted December 9, 2025
Johnson & Johnson is enrolling eligible participants to AZALEA, 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). The safety and efficacy profile of this investigational medication in this patient population has not been established.
Participants in this clinical trial will be randomly assigned to receive an infusion of either the active investigational medication or a placebo (2:1). Participation in the trial includes up to 23 weekly intravenous infusions while visiting the trial clinic during pregnancy. After the child’s birth, the participant will have a trial follow-up period of 24 weeks, and the child will have a trial follow-up period of 2 years.
Patients may be eligible to participate in the AZALEA trial if they:
- Have tested positive for red cell antibodies
- Have been diagnosed with HDFN in a prior pregnancy
- Are 18 to 45 years old
Early referral of potential participants to study sites is recommended to ensure screening and enrollment within the study timelines. Please complete this short form if you’d like to be introduced to your closest AZALEA study site in the U.S.
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopeniaposted December 9, 2025
FREESIA-1 is a double-blind placebo-controlled global multicenter randomized research study of an investigational FcRn inhibitor called nipocalimab in pregnant adults at standard-risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT) characterized by the absence of intracranial hemorrhage or severe bleeding in the previously affected sibling. The safety and efficacy profile of this investigational medicine in this patient population has not been established.
FNAIT is a rare condition marked by low platelet counts in the fetus or newborn, resulting from incompatibility between maternal and fetal human platelet antigens (HPA). In this study, participants will be monitored rigorously: mothers will be observed for up to 6 months postpartum, while infants will be followed for a period of 2 years.
Participants will be asked to
- Visit the site weekly during pregnancy and a few times postpartum.
Eligibility
- Pregnant individuals aged 18 to 45 years at gestational age week 130/7 to 186/7
- A prior pregnancy affected by FNAIT without intracranial hemorrhage or severe bleeding
- Generally healthy with a singleton pregnancy