ArticleAmerican journal of perinatology2025
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.
Article in American journal of perinatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed.
- Nipocalimab Phase 3 Dose Selection for Severe Hemolytic Disease of the Fetus and Newborn.Journal of clinical pharmacology · 2026Trial
- Trial
- Effect of nipocalimab on IgG responses to vaccinations and viral infections in patients with IgG autoantibody-mediated diseases: Post hoc analyses of three randomized, placebo-controlled trials.Human vaccines & immunotherapeutics · 2026Observational
- Study Design of the Global Prospective Hemolytic Disease of the Fetus and Newborn Registry (GERANIUM).American journal of perinatology · 2026Article
- The Ethics of Clinical Research on Diseases of the Fetus and Newborn: Balancing Benefit-Risk, Autonomy, and Maternal-Fetal Interests.American journal of perinatology · 2026Review
- In Utero Molecular-Targeted Drug Therapies: Translational Principles, Pharmacologic Considerations, and Emerging Clinical Applications.Journal of clinical medicine · 2026Review
- B Cells and B Cell Depletion in Autoimmunity and Atherosclerosis.Life (Basel, Switzerland) · 2026Review
- Understanding the consequences of being RhD immunized during pregnancy 10 years after introduction of targeted routine antenatal anti-D prophylaxis: A retrospective nationwide cohort study.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Article
- Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia.American journal of perinatology · 2026Article
- Maternal Immunoglobulin Treatment of Gestational Alloimmune Liver Disease to Prevent Neonatal Liver Failure: A Single Center Case Series.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2025Article
- Noninvasive fetal antigen genotyping: Results from a survey on the status of clinical implementation.Vox sanguinis · 2025Article
- Red blood cell alloimmunization and pregnancy: Diagnosis and management.Pregnancy (Hoboken, N.J.) · 2025Review
- Nipocalimab: First Approval.Drugs · 2025Review
- Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nipocalimab is a neonatal fragment crystallizable (Fc) receptor (FcRn)-blocking monoclonal antibody that inhibits placental immunoglobulin G (IgG) transfer and lowers circulating maternal IgG levels. In an open-label, single-arm, phase 2 study, nipocalimab demonstrated evidence of safety and efficacy that support further investigation in a pivotal phase 3 trial of recurrent hemolytic disease of the fetus and newborn (HDFN). The phase 3 AZALEA study aims to evaluate the efficacy and safety of nipocalimab in a larger population at risk for severe HDFN, defined as HDFN associated with poor fetal outcomes or neonatal death.AZALEA is a multicenter, randomized, placebo-controlled, double-blind, phase 3 study enrolling alloimmunized pregnant individuals (
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