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Nipocalimab versus IVIG in pregnancies at risk of severe FNAIT
NL-OMON59906Phase 3Not yet recruiting
- Sponsor
- Janssen Pharmaceutical
- Start
- Oct 2025
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, open-label trial in fetomaternal alloimmune thrombocytopenia (FMAIT) comparing Nipocalimab with IVIG (2 arms). Primary endpoint: Composite adverse fetal or neonatal outcome. Planned start Oct 2025; status: not yet recruiting.
02
Drugs
nipocalimabimmune globulin
03
Conditions
fetomaternal alloimmune thrombocytopenia (FMAIT)
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