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NCT Number: NCT06533098

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

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).

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Key information

Conditions

Thrombocytopenia, Neonatal Alloimmune Blood Platelet Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases Thrombocytopenia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Universitaet Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant and an estimated gestational age (GA) from week 13* to 18 at visit 1

*Randomization for high-risk FNAIT participants to occur at GA Week 12

  • Has a history of greater than or equal to (>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (<) 150*10^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
  • Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
  • Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
  • For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion criteria

  • Currently pregnant with multiple gestations (twins or more)
  • History of severe preeclampsia in a previous pregnancy
  • History of myocardial infarction, unstable ischemic heart disease, or stroke
  • Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone
  • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Treatment and study plan

Nipocalimab

Drug

Nipocalimab will be administered intravenously.

Other names: JNJ-80202135, JNJ-86507083, M281

intravenous immunoglobulins (IVIG)

Drug

IVIG will be administered intravenously.

Prednisone

Drug

Prednisone will be administered orally.

Primary outcomes

  1. Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L

    Time frame: Up to 1 Week post birth

    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.

Secondary outcomes

  1. Platelet Count at Birth in a Neonate

    Time frame: At birth

    Platelet count at birth in a neonate will be reported.

  2. Neonate/Fetus with Outcome of Death

    Time frame: Up to 1 Week post birth

    Fetus/neonate with outcome of death will be reported.

  3. Neonate with Platelet Count at Birth <10*10^9/L

    Time frame: At birth

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

  4. Neonate with Platelet Count at Birth <30*10^9/L

    Time frame: At birth

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

  5. Neonate with Platelet Count at Birth <50*10^9/L

    Time frame: At birth

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

  6. Neonate with Platelet Count at Birth <150*10^9/L

    Time frame: At birth

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

  7. Nadir Platelet Count in a Neonate

    Time frame: Up to 1 Week post birth

    Nadir platelet count in a neonate will be reported.

  8. Neonate Requiring Platelet Transfusion

    Time frame: Up to 1 Week post birth

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

  9. Number of Platelet Transfusions in Neonate

    Time frame: Up to 1 Week post birth

    Number of platelet transfusions per neonate will be reported.

  10. Number of Donor Exposures for Platelet Transfusions in Neonate

    Time frame: Up to 1 Week post birth

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

  11. Neonate/Fetus With Adjudicated Bleeding

    Time frame: Up to 1 Week post birth

    Neonate/Fetus with adjudicated bleeding will be reported.

  12. Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia

    Time frame: Up to 1 Week post birth

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

  13. Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)

    Time frame: Up to Week 24

    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.

  14. Maternal Participant with TEAE Leading to Discontinuation of Study Intervention

    Time frame: Up to Week 24

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

  15. Neonate/Infant With TEAE, SAE and AESI

    Time frame: From Day of birth to Week 104

    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.

  16. Fetus/Neonate with a TEAE of Bleeding

    Time frame: From Day of birth to Week 104

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

  17. Neonate with a TEAE of Infection

    Time frame: From Day of birth to Week 104

    Neonate with a TEAE of infection will be reported.

  18. Bayley Scales Assessment for Infant Development

    Time frame: At Week 52 and Week 104

    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.

  19. Maternal Participants with Incidence of Antibodies to Nipocalimab

    Time frame: Up to Week 4

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: FREESIA-3

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 1, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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