FREESIA-3
Classical hematology
A Phase 3, randomized,multicenter, open-label study of nipocalimab or IVIG in pregnancies at risk of FNAIT
Phase
Compound
Nipocalimab (anti-FcRn mAb)
NCT identifier
NCT06533098
Enrollment
N=~50
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Study overview & design
Key eligibility criteria*:
- Pregnant and an estimated GA from Week 13† to 18 at Visit 1
- History of pregnancy with FNAIT
- Standard risk: neonatal platelet count <150 × 109/L with no fetal/neonatal intracranial hemorrhage or severe fetal/neonatal hemorrhage, or
- High risk: fetus/neonate with intracranial hemorrhage or severe hemorrhage in a fetus/neonate
- Presence of maternal anti–HPA-1a and/or anti–HPA-5b alloantibody and positive fetal HPA-1a and/or anti–HPA-5b genotype in current pregnancy
- No history of severe preeclampsia in previous pregnancy
Study
design
Primary outcome:
- Fetus/neonate with outcome of death or adjudicated severe bleeding or platelet count <30 × 109/L
Secondary outcomes‡:
- Platelet count at birth in a neonate
- Neonate/fetus with outcome of death
- Neonate requiring platelet transfusion
- Neonate/fetus with adjudicated bleeding
- Safety in mother and neonate/fetus/infant
*Not a complete list of inclusion and exclusion criteria. †Randomization for high-risk FNAIT participants to occur at GA Week 12. ‡Not a complete list of secondary outcomes.
FcRn, neonatal crystallizable fragment receptor; FNAIT, fetal and neonatal alloimmune thrombocytopenia; GA, gestational age; HPA, human platelet antigen; IV, intravenous; IVIG, intravenous immunoglobulin; mAb, monoclonal antibody; PO, orally; R, randomized.