Design of a Phase 3, Global, Multicenter, Randomized, Placebo-controlled, Double-blind Study of Nipocalimab in Pregnancies At-risk for Severe Hemolytic Disease of the Fetus and Newborn.

AZALEA, the first placebo-controlled, randomized, multicenter, prospective trial in severe HDFN, is designed to evaluate the safety and efficacy of nipocalimab, a potential preventive and noninvasive intervention, in at-risk HDFN pregnancies.