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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Nipocalimab
  Nipocalimab will be administered intravenously.
• Препарат Placebo
  Placebo will be administered intravenously.

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)

• Neonate/Fetus With Adjudicated Bleeding [Срок оценки: Up to 1 Week post birth]
• 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]
• Platelet Count at Birth <10×10^9/L in a Neonate [Срок оценки: At birth]
• Platelet Count at Birth <30×10^9/ L In a Neonate [Срок оценки: At birth]
• Platelet Count at Birth <50×10^9/L In a Neonate [Срок оценки: At birth]
• Platelet Count at Birth <150×10^9/L In a Neonate [Срок оценки: At birth]
• Nadir Platelet Count of a Neonate Over the First Week Post Birth [Срок оценки: Upto 1 Week post birth]
• Neonate/Fetus Requiring Platelet Transfusion(s) [Срок оценки: Up to 1 Week post birth]
• Number of Platelet Transfusion(s) in Neonate/Fetus [Срок оценки: Up to 1 Week post birth]
• Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus [Срок оценки: Up to 1 Week post birth]
• Neonate/Fetus With Adjudicated Severe Bleeding [Срок оценки: Up to 1 week post birth]

Критерии участия

Критерии включения

• 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

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 (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

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Норвегия · 4 центра

• Haukeland University Hospital — Bergen
• Oslo University Hospital HF Ulleval sykehus — Oslo
• Universitetssykehuset Nord-Norge HF — Tromsø
• St. Olavs Hospital — Trondheim

Бразилия · 3 центра

• Instituto de Medicina Integral Professor Fernando Figueira — Recife
• Instituto D Or de Pesquisa e Ensino IDOR — Rio de Janeiro
• Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo

Словакия · 3 центра

• Univerzitna nemocnica L. Pasteura Kosice — Košice
• Univerzitná nemocnica Martin — Martin
• Fakultna nemocnica s poliklinikou Nove Zamky — Nové Zámky

Франция · 2 центра

• CHRU Lille — Lille
• Hopital trousseau- APHP — Paris

Италия · 2 центра

• Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico — Milan
• Fondazione Policlinico Universitario A Gemelli IRCCS — Rome

Бельгия · 1 центр

• Universitair Ziekenhuis Leuven — Leuven

Венгрия · 1 центр

• Semmelweis Egyetem — Budapest

Израиль · 1 центр

• Sheba Medical Center — Ramat Gan

Словения · 1 центр

• Univerzitetni klinicni center Ljubljana — Ljubljana

Испания · 1 центр

• Hosp. Virgen Del Rocio — Seville

Швеция · 1 центр

• Karolinska Universitetssjukhuset Huddinge — Stockholm

Швейцария · 1 центр

• Centre Hospitalier Universitaire Vaudois CHUV — Lausanne

Публикации

• Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Apr;43(5):648-656. doi: 10.1055/a-2666-5642. Epub 2025 Jul 28. PMID 40720970

Идентификаторы

NCT: NCT06449651 · 80202135FNAIT3001 · 80202135FNAIT3001 · 2023-504307-88-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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