FNAIT research matters to all of us

This section of the website is only for HCPs in the United States.
HCPs outside the United States should go to ClinicalTrials.gov (NCT06533098).

This image depicts models and is for illustrative purposes only.

This section of the website is only for HCPs in the United States. HCPs outside the United States should go to ClinicalTrials.gov (NCT06533098).

About the study

FREESIA-3 is a phase 3, open-label, randomized study to assess the efficacy of an investigational medication, nipocalimab, and intravenous immunoglobulin (IVIG) in pregnancies at risk for FNAIT. The safety and efficacy of the investigational medication have not been established.

Who is eligible to participate?

Eligible participants will:

Be at least 18 years of age or older
Be pregnant with an estimated gestational age between Weeks 8^0/7 and 15^6/7 (based on ultrasound)
Have a history of ≥1 prior pregnancy with FNAIT including:
- - Neonatal platelet count <150 x 10⁹/L with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR
  - Fetus/neonate with ICH or severe hemorrhage in a previous child based on medical records (high-risk)
Have a current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or anti-HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood from testing provided by the study

Additional criteria will apply.

This image depicts models and is for illustrative purposes only.

What happens during the study

Total participation will last up to 140 weeks (about 3 years). This includes screening for eligibility, study intervention dosing, and follow-up for participants and their neonates/infants
Eligible participants will be randomized 4:1 to receive nipocalimab or IVIG
All participants will receive their study intervention (nipocalimab or IVIG) intravenously every 7 days until delivery
- Participants receiving nipocalimab will receive 23 to 28 IV infusions during their pregnancy
- Participants randomized to IVIG will receive their infusions according to Bussel 2021 AJOG^a
After giving birth, participants will have 3 study clinic visits over the course of 6 months. The first visit will take place before they are discharged from the hospital. The participant’s child will have 6 study visits over the course of 2 years. Visit 1 will occur at birth, and Visit 2 will take place before they are discharged from the hospital.

All participants will receive:

Medication and medical care required by the clinical trial at no cost
Reimbursement for travel and expenses required by the clinical trial

Participants will not be paid for other medical care or medications that are not part of the clinical trial.

Map of planned study sites

The map below lists the locations where the FREESIA-3 study will be conducted. Study sites will be opening throughout 2025. Actual site locations may vary. Please reference ClinicalTrials.gov for the most up to date site locations.

Aurora, CO
Birmingham, AL
Boston, MA
Chapel Hill, NC
Cincinnati, OH
Detroit, MI
Gainesville, FL
Galveston, TX
Iowa City, IA

Miami, FL
Nashville, TN
New Brunswick, NJ
Norfolk, VA
Park Ridge, IL
Philadelphia, PA
Portland, OR
Sacramento, CA
Salt Lake City, UT

Aurora, CO
Birmingham, AL
Boston, MA
Chapel Hill, NC
Cincinnati, OH

Detroit, MI
Gainesville, FL
Galveston, TX
Iowa City, IA
Miami, FL

Nashville, TN
New Brunswick, NJ
Norfolk, VA
Park Ridge, IL
Philadelphia, PA

Portland, OR
Sacramento, CA
Salt Lake City, UT

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ONCE STUDY SITES ARE OPEN:

This image depicts models and is for illustrative purposes only.

^aBussel JB, Vander Haar EL, Berkowitz RL. New developments in fetal and neonatal alloimmune thrombocytopenia. Am J Obstet Gynecol. 2021;225(2):120-127.

FNAIT research matters to all of us

About the study

Who is eligible to participate?

What happens during the study

Map of planned study sites

SIGN UP TO BE CONTACTED ONCE STUDY SITES ARE OPEN:

SIGN UP TO BE CONTACTED
ONCE STUDY SITES ARE OPEN: