About the Azalea Trial

The purpose of the Azalea Trial is to evaluate the efficacy and safety of an investigational medication in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN).

Who Is Eligible to Participate?

There are several requirements to participate in the Azalea Trial. The trial clinic will discuss and evaluate these requirements with all potential participants.

You may be able to participate in the Azalea Trial if you:

  • Have tested positive for red cell antibodies to RhD, Kell, Rhc, RhE, or RhC antigen
  • Have been diagnosed with HDFN in a prior pregnancy
  • Are 18 to 45 years old
  • Are currently pregnant

Early referral is critical to participation in the Azalea Trial. You are encouraged to complete the questionnaire on this website today to ensure that you are referred to a trial clinic in a timely manner. Feel free to complete it even if you’re not currently pregnant but are planning on becoming pregnant.

You may not be eligible to participate in the Azalea Trial if you:

  • Are pregnant with more than one baby, such as twins or triplets
  • Have received or plan to receive any of the following treatments during your current pregnancy:
    • Plasmapheresis
    • Immunoadsorption therapy
    • Intravenous immunoglobulin (IVIg)
    • Any related protein (IgG Fc) therapies
  • Have inflammatory or autoimmune diseases that require immunosuppressive (immune system–suppressing) treatments
For more information, download the participant fact sheet.
  • Participation in this clinical trial includes approximately 18–23 weekly intravenous (IV) infusions while visiting the trial clinic during your pregnancy. There are about 27 total visits to the clinic before the birth of your child.
  • After your child’s birth, you will have 3 additional trial clinic visits over the course of 6 months, and your child will have 6 trial clinic visits over the course of 2 years.
  • As a participant in the Azalea Trial, you will be randomly assigned to receive an infusion of either the active investigational medication or a placebo (placebo looks like the investigational medication but does not contain any active medication). You have a 2-in-3 chance of receiving the investigational medication.
  • You and your baby will be closely monitored during the trial and will receive the same level of care no matter which group you are assigned to. If there is a change in your or your baby’s health while you are participating, the trial doctor will inform you immediately and will discuss your options, as your physical and mental health are of paramount importance.

All participants will receive trial-required medication and trial-required medical care at no cost. Participants will also be reimbursed for trial-required travel and expenses. You will not be paid for other medical care or medications that are not part of the trial.

The investigational medication has not been approved for use by the FDA. This clinical trial is an important step in the process before the FDA can determine if the investigational medication is safe and effective for patients.

For more information, download the placebo fact sheet.

Patient Resources Library:

Learn more about HDFN and find support.