About HFDN (Hemolytic disease of the fetus and newborn)

Hemolytic disease of the fetus and newborn (HDFN) is a rare disease that impacts approximately 3-80 out of 100,000 pregnancies annually.1 HDFN, which occurs when the mother and baby’s blood types aren’t compatible, can lead to serious complications for the baby including anemia, jaundice, or edema.

For Patients

Azalea, a clinical research study for women with pregnancies at risk for severe HDFN is
currently enrolling. The purpose of the study is to assess the safety and efficacy of an
investigational medication in pregnancies at risk for severe HDFN.
You may be able to participate in the Azalea study if you:

• Have tested positive for red cell antibodies
• Have been diagnosed with HDFN in a prior pregnancy
• Are 18 to 45 years old

Additional eligibility criteria will be assessed by the study doctor or staff during the
screening process prior to being enrolled in the study. Not all individuals may qualify for
this study.

Azalea is a global study with participating study clinics in North America (U.S. and
Canada), Asia, Australia, Europe, and South America. If you are located in the U.S. and
would like to learn more about this study, please visit the Azalea Trial website and
complete the questionnaire on the website to see if you may qualify. You are encouraged
to complete the questionnaire on the website even if you’re not currently pregnant but are
planning on becoming pregnant.

For Healthcare Providers

Are you treating a patient who received an HDFN diagnosis during a previous pregnancy?
Are they currently pregnant or planning a pregnancy? If so, consider telling them about
Azalea, a clinical trial for women with pregnancies at risk for severe HDFN.

The Azalea Trial is enrolling patients who:

• Have tested positive for red cell antibodies
• Have been diagnosed with HDFN in a prior pregnancy
• Are 18 to 45 years old

Additional eligibility criteria will be assessed by the study team. Potential participants will
be asked to attend a screening visit with the study doctor where they will undergo tests and
procedures to determine if they are an appropriate match for participating in the study.
Azalea is a global study with participating study clinics in North America (U.S. and Canada)
as well as Asia, Australia, Europe, and South America. If you would like to learn more about this study, please visit https://clinicaltrials.gov and search for NCT05912517.

*Participants in the Azalea study will be randomly assigned to receive an infusion of the
investigational medication; this can be the active investigational medication or placebo (a
liquid that contains no active ingredients; the randomization ratio is 2:1, respectively). All
participants in the trial will be reimbursed for study required travel and receive study
required medical care at no cost.