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AZALEA: Nipocalimab for Pregnancies at Risk for Severe HDFN
jRCT2041240016Phase 3Recruiting
- Sponsor
- Janssen Pharmaceutical
- Start
- Jul 2025
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
01
Overview
Phase 3, randomised, double-blind trial in Erythroblastosis fetalis (HDFN) comparing Nipocalimab arm with Placebo arm (2 arms). Primary endpoint: Percentage of pregnancies without fetal loss, IUT, hydrops fetalis, or neonatal death. Started Jul 2025; status: recruiting.
02
Drugs
nipocalimab
03
Conditions
Erythroblastosis fetalis (HDFN)
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