A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT Number: NCT06533098
Acronym: FREESIA-3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Thrombocytopenia, Neonatal Alloimmune
Interventions: DRUG: Nipocalimab|DRUG: Intravenous immunoglobulins (IVIG)|DRUG: Prednisone
Sponsor: Janssen Research & Development, LLC
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-22
Completion Date: 2029-12-05

Summary:
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).

Primary Outcome Measures: Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L, 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., Up to 1 Week post birth
Secondary Outcome Measures: Platelet Count at Birth in a Neonate, Platelet count at birth in a neonate will be reported., At birth|Neonate/Fetus with Outcome of Death, Fetus/neonate with outcome of death will be reported., Up to 1 Week post birth|Neonate with Platelet Count at Birth <10*10^9/L, Platelet count at birth \<10\*10\^9/L in a neonate will be reported., At birth|Neonate with Platelet Count at Birth <30*10^9/L, Platelet count at birth \<30\*10\^9/L in a neonate will be reported., At birth|Neonate with Platelet Count at Birth <50*10^9/L, Platelet count at birth \<50\*10\^9/L in a neonate will be reported., At birth|Neonate with Platelet Count at Birth <150*10^9/L, Platelet count at birth \<150\*10\^9/L in a neonate will be reported., At birth|Nadir Platelet Count of a Neonate, Nadir platelet count in a neonate will be reported., Up to 1 Week post birth|Neonate Requiring Platelet Transfusion, Neonate who require at least one platelet transfusion will be reported., Up to 1 Week post birth|Number of Platelet Transfusions in Neonate, Number of platelet transfusions per neonate will be reported., Up to 1 Week post birth|Number of Donor Exposures for Platelet Transfusions in Neonate, Number of donor exposures for a neonate who received at least one platelet transfusion will be reported., Up to 1 Week post birth|Neonate/Fetus With Adjudicated Bleeding, Neonate/Fetus with adjudicated bleeding will be reported., Up to 1 Week post birth|Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia, Neonate requiring IVIG for the treatment of thrombocytopenia will be reported., Up to 1 Week post birth|Neonate/Infant With Treatment-emergent Adverse Events (TEAEs) of Infection, Neonate/infant with TEAE of Infection 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. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment., From Day of birth to Week 104