AZALEA
Classical hematology
A Phase 3, randomized, placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of nipocalimab-aahu in pregnancies at risk for severe HDFN
Phase
Compound
Nipocalimab-aahu (anti-FcRn mAb)
NCT identifier
NCT05912517
Enrollment
N=~120
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 (based on ultrasound dating) from Week 13, Day 0/7 to Week 18, Day 6/7 at randomization
- History of severe HDFN in a prior pregnancy
- Evidence of antigen positivity corresponding to maternal alloantibodies (Kell, RhD, Rhc, RhE, or RhC)
- No prior evidence of fetal anemia in the current pregnancy
- No current uncontrolled hypertension
- No current malignancy or history of malignancy within 3 years before screening
Study
design
Primary outcome:
- Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death
Secondary outcomes†:
- HDFN by severity
- Time to first occurrence of IUT or hydrops fetalis
- Assessment of NMMI in liveborn neonates
- Number of IUTs received
- Fetal loss
- Fetal or neonatal death
- Hydrops fetalis
- Safety
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of secondary outcomes.
GA, gestational age; HDFN, hemolytic disease of the fetus and newborn; IUT, intrauterine transfusion; IV, intravenous; NMMI, neonatal mortality and morbidity index; QW, weekly; R, randomized; Rh, Rhesus antigen.