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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Nipocalimab
  Nipocalimab will be administered intravenously.
• Препарат Intravenous immunoglobulins (IVIG)
  IVIG will be administered intravenously.
• Препарат Prednisone
  Prednisone will be administered orally.

Первичные конечные точки

• Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L [Срок оценки: Up to 1 Week post birth]

Вторичные конечные точки (12)

• Platelet Count at Birth in a Neonate [Срок оценки: At birth]
• Neonate/Fetus with Outcome of Death [Срок оценки: Up to 1 Week post birth]
• Neonate with Platelet Count at Birth <10*10^9/L [Срок оценки: At birth]
• Neonate with Platelet Count at Birth <30*10^9/L [Срок оценки: At birth]
• Neonate with Platelet Count at Birth <50*10^9/L [Срок оценки: At birth]
• Neonate with Platelet Count at Birth <150*10^9/L [Срок оценки: At birth]
• Nadir Platelet Count in a Neonate [Срок оценки: Up to 1 Week post birth]
• Neonate Requiring Platelet Transfusion [Срок оценки: Up to 1 Week post birth]
• Number of Platelet Transfusions in Neonate [Срок оценки: Up to 1 Week post birth]
• Number of Donor Exposures for Platelet Transfusions in Neonate [Срок оценки: Up to 1 Week post birth]
• Neonate/Fetus With Adjudicated Bleeding [Срок оценки: Up to 1 Week post birth]
• Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia [Срок оценки: Up to 1 Week post birth]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• The University of Alabama at Birmingham — Birmingham
• UC Davis School of Medicine — Sacramento
• Childrens Hospital Colorado — Aurora
• Advocate Children's Hospital — Park Ridge
• University of Iowa Hospital and Clinics — Iowa City
• University of Rochester Medical Center — Rochester
• University of North Carolina at Chapel Hill — Chapel Hill
• University of Cincinnati — Cincinnati
• … и ещё 4 центра

Германия · 4 центра

• Universitaetsklinikum Giessen und Marburg GmbH — Giessen
• Medizinische Hochschule Hannover — Hanover
• Universitatsklinikum Jena — Jena
• Universitaetsklinikum Tuebingen — Tübingen

Великобритания · 4 центра

• Birmingham Women's Hospital — Birmingham
• Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital — Liverpool
• Queen Charlotte's and Chelsea Hospital — London
• John Radcliffe Hospital — Oxford

Польша · 3 центра

• Instytut Centrum Zdrowia Matki Polki — Lodz
• Instytut Matki i Dziecka — Warsaw
• Panstwowy Instytut Medyczny MSWiA w Warszawie — Warsaw

Австрия · 2 центра

• Medizinische Universitaet Graz — Graz
• Medical University Vienna — Vienna

Нидерланды · 1 центр

• Leiden University Medical Center — Leiden

Публикации

• Bussel J, Stegmann B, Baker P, Oey A, Jiang Y, Zaha R, Van Valkenburgh H, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(10):1335-1344. doi: 10.1055/a-2753-9323. Epub 2025 Nov 25. PMID 41290206

Идентификаторы

NCT: NCT06533098 · 80202135FNAIT3003 · 2023-509434-19-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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