The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing
the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Thrombocytopenia, Neonatal Alloimmune

Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT)

Autoantibody diseases

Immune system conditions

Prednisone

Nipocalimab

Intravenous immunoglobulins (IVIG)

Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post
birth or platelet count <30*10^9/L will be reported.

Platelet count at birth in a neonate will be reported.

Fetus/neonate with outcome of death will be reported.

Platelet count at birth <10*10^9/L in a neonate will be reported.

Platelet count at birth <30*10^9/L in a neonate will be reported.

Platelet count at birth <50*10^9/L in a neonate will be reported.

Platelet count at birth <150*10^9/L in a neonate will be reported.

Nadir platelet count in a neonate will be reported.

Neonate who require at least one platelet transfusion will be reported.

Number of platelet transfusions per neonate will be reported.

Number of donor exposures for a neonate who received at least one platelet transfusion
will be reported.

Neonate/Fetus with adjudicated bleeding will be reported.

Neonate requiring IVIG for the treatment of thrombocytopenia will be reported.

Maternal participant with TEAE, SAE and AESI will be reported. An Adverse event (AE) is
any untoward medical occurrence in a participant participating in a clinical study that
does not necessarily have a causal relationship with the intervention under study.

Maternal participant with TEAE leading to discontinuation of study intervention will be
reported.

Neonate/infant with TEAE, SAE and AESI will be reported. An AE is any untoward medical
occurrence in a participant participating in a clinical study that does not necessarily
have a causal relationship with the intervention under study.

Fetus/Neonate with a TEAE of bleeding will be reported.

Neonate with a TEAE of infection will be reported.

The Bayley Scales of infant development is considered the standard assessment of early
child development and includes cognition, language, motor skills, social emotional, and
adaptive behavior will be reported. The Bayley Scales are reference standards that
measure infant and toddler development in five areas: cognition, language, motor skills,
social-emotional and adaptive behavior. The cognition, language and motor skills scales
are directly administered to the infant, while social-emotional, and adaptive behavior
scales are caregiver questionnaires. The scores are standardized using norm reference
samples with representative demographics and age adjusted for prematurity. Higher scores
in the Bayley Scales indicate better outcomes.

Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal
serum during pregnancy and postpartum will be reported.

Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized
to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before
delivery.

Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized
to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk
pregnancies. Additionally, prednisone will be added per study protocol. Participants will
be gradually tapered off prednisone after delivery as per investigator judgement or
maternal participant tolerance.

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Trials at a glance

Trials at a glance

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Outcome measures

Primary outcome measures

Secondary outcome measures