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NCT Number: NCT06449651

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo 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

Universitair Ziekenhuis Leuven, Leuven, Belgium

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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; based on ultrasound dating) from Week 13 to 18 at randomization
  • Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
  • Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (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 (refer to the Investigator Brochure (IB))
  • 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

Placebo

Drug

Placebo will be administered intravenously.

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. Neonate/Fetus With Adjudicated Bleeding

    Time frame: Up to 1 Week post birth

    Neonate/fetus With adjudicated bleeding will be reported.

  2. Platelet Count at Birth in a Neonate

    Time frame: At birth

    Platelet count at birth in a neonate will be reported.

  3. Neonate/Fetus with Outcome of Death

    Time frame: Up to 1 Week post birth

    Fetus/neonate with outcome of death will be reported.

  4. Platelet Count at Birth <10×10^9/L in a Neonate

    Time frame: At birth

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

  5. Platelet Count at Birth <30×10^9/ L In a Neonate

    Time frame: At birth

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

  6. Platelet Count at Birth <50×10^9/L In a Neonate

    Time frame: At birth

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

  7. Platelet Count at Birth <150×10^9/L In a Neonate

    Time frame: At birth

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

  8. Nadir Platelet Count of a Neonate Over the First Week Post Birth

    Time frame: Upto 1 Week post birth

    Nadir platelet count in a neonate will be reported.

  9. Neonate/Fetus Requiring Platelet Transfusion(s)

    Time frame: Up to 1 Week post birth

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

  10. Number of Platelet Transfusion(s) in Neonate/Fetus

    Time frame: Up to 1 Week post birth

    Number of Platelet transfusion(s) per neonate will be reported.

  11. Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus

    Time frame: Up to 1 Week post birth

    Number of donor exposures for neonates who received platelet transfusion(s) will be reported.

  12. Neonate/Fetus With Adjudicated Severe Bleeding

    Time frame: Up to 1 week post birth

    Neonate/Fetus With adjudicated severe bleeding will be reported.

  13. Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia

    Time frame: Up to 1 Week post birth

    Neonates with IVIG for the treatment of thrombocytopenia will be reported.

  14. Maternal Participants With Treatment-Emergent Adverse Event (TEAE)

    Time frame: From randomization up to 24 weeks postpartum

    Maternal participants with a TEAE 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  15. Maternal Participants With Serious Adverse Event (SAE)

    Time frame: From randomization up to 24 weeks postpartum

    Maternal participants with SAE 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. SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically important.

  16. Maternal Participants With Adverse Event of Special Interest (AESI)

    Time frame: From randomization up to 24 weeks postpartum

    Maternal participants with an 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. AESIs are considered as infections that are severe, hypoalbuminemia, deep vein thrombosis and/or pulmonary embolism, and clinically significant bleeding.

  17. Maternal Participants with TEAE Leading to Discontinuation of Study Intervention

    Time frame: Up to Week 104

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

  18. Neonate/Infant with TEAE

    Time frame: Up to Week 104

    Neonatal/infant participants with a TEAE 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  19. Neonate/Infant with SAE

    Time frame: Up to Week 104

    Neonatal/infant participants with SAE 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. An SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically Important.

  20. Neonate/Infant with AESI

    Time frame: Up to Week 104

    Neonatal/infant participants with 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. AESIs are considered as: In infants- clinically significant mortalities in fetus/neonates due to maternal infections, and hypogammaglobulinemia.

  21. Fetus/Neonate With TEAE of Bleeding

    Time frame: Up to Week 104

    Fetus/Neonate with TEAE of Bleeding 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. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  22. Neonate With TEAE of Infection

    Time frame: Up to Week 104

    Neonate 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.

  23. Infant Development as Measured by Bayley Scales at Week 52 and Week 104

    Time frame: At Week 52 and 104

    The Bayley Scales of Infant and Toddler Development include a set of individually administered developmental scales designed to measure current developmental functioning in infants and toddlers up to 42 months of age in the areas of cognition, language, motor skills, social-emotional, and adaptive behavior, with age adjusted for prematurity. The cognition, language, 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.

  24. Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum

    Time frame: Up to Week 24

    Maternal participants with 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

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Acronym: FREESIA-1

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2024
Registry last updated
Jul 24, 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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