Multicentre, Open-Label, Randomised Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (FREESIA-3)

Research summary

This is a global open-label, randomized, multicenter, interventional study in pregnant participants with a prior FNAIT-affected pregnancy to assess the efficacy, safety, tolerability, PK, PD, and immunogenicity of nipocalimab or IVIG. ‘IVIG’ throughout the protocol will be referring to the IVIG with or without prednisone regimen adapted from Bussel et al (Bussel 2021). The studywill target participants whose current pregnancies are affected by HPA-1a and/or HPA-5b incompatibility. Maternal participants with alloantibodies against both HPA-1a and HPA-5b will be categorized under HPA-1a (further referred to as HPA-1a). Initial enrollment will include maternal participants without a prior ICH or severe hemorrhage in the fetus or newborn defined as standard-risk for FNAIT (further referred to as standard-risk participants). The maternal participants with high-risk FNAIT pregnancies (ie, with a prior ICH or severe hemorrhage in the fetus or newborn, further referred to as high-risk participants) will be enrolled based on the recommendation by the independent DMC following the assessment of the interim analysis (from Study 80202135FNAIT3001, involving approximately 15 standard-risk participants.

Principal Investigator

Christina Aye

Contact us

Email: osprea@wrh.ox.ac.uk

IRAS number

1010250