FREESIA-1
Classical hematology
A Phase 3, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of nipocalimab-aahu in reducing the risk of FNAIT in at-risk pregnancies
Phase
Compound
Nipocalimab-aahu (anti-FcRn mAb)
NCT identifier
NCT06449651
Enrollment
N=~39
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Pregnant and an estimated GA from Week 13 to 18 at randomization
- History of pregnancy with FNAIT unaffected by fetal/neonatal intracranial hemorrhage or severe hemorrhage
- Presence of maternal anti–HPA-1a alloantibody and positive fetal HPA-1a genotype in current pregnancy
- No history of severe preeclampsia in previous pregnancy
Study
design
Primary outcome:
- Fetus/neonate with outcome of death or adjudicatedsevere bleeding or platelet count <30 × 109/L
Secondary outcomes†:
- Neonate/fetus with adjudicated bleeding
- Platelet count at birth in a neonate
- Neonate/fetus with outcome of death
- Safety in mother and neonate/fetus/infant
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
FNAIT, fetal and neonatal alloimmune thrombocytopenia; GA, gestational age; HPA, human platelet antigen; IV, intravenous; R, randomized.