Um estudo de nipocalimabe na redução do risco de trombocitopenia aloimune fetal e neonatal (FNAIT) (FREESIA-1)
Estudo duplo-cego, randomizado e controlado por placebo que avalia a segurança e eficácia do nipocalimabe na redução do risco de trombocitopenia aloimune fetal e neonatal (FNAIT) em gestações de risco
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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Study Contact
- Número de telefone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Locais de estudo
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Recife, Brasil, 50070-902
- Concluído
- Instituto de Medicina Integral Professor Fernando Figueira
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Rio de Janeiro, Brasil, 22281 100
- Concluído
- IDOR - Regional Rio de Janeiro
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São Paulo, Brasil, 05403 000
- Concluído
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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Leuven, Bélgica, 3000
- Concluído
- Universitair Ziekenhuis Leuven
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Košice, Eslováquia, 04190
- Concluído
- Univerzitna nemocnica L. Pasteura Kosice
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Martin, Eslováquia, 036 01
- Concluído
- Univerzitná nemocnica Martin
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Nové Zámky, Eslováquia, 940 34
- Concluído
- Fakultna nemocnica s poliklinikou Nove Zamky
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Ljubljana, Eslovênia, 1000
- Concluído
- Univerzitetni klinicni center Ljubljana
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Seville, Espanha, 41013
- Concluído
- Hosp. Virgen Del Rocio
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Lille, França, 59000
- Concluído
- CHRU Lille
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Paris, França, 75012
- Concluído
- Hopital trousseau- APHP
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Budapest, Hungria, 1082
- Recrutamento
- Semmelweis Egyetem
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Ramat Gan, Israel, 5262000
- Concluído
- Sheba Medical Center
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Milan, Itália, 20122
- Concluído
- Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
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Rome, Itália, 00168
- Concluído
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Bergen, Noruega, 5009
- Recrutamento
- Haukeland University Hospital
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Oslo, Noruega, 0455
- Recrutamento
- Oslo University Hospital HF Ulleval sykehus
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Tromsø, Noruega, 9019
- Recrutamento
- Universitetssykehuset Nord-Norge HF
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Trondheim, Noruega, 7030
- Recrutamento
- St. Olavs Hospital
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Stockholm, Suécia, SE-141 86
- Recrutamento
- Karolinska Universitetssjukhuset Huddinge
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Lausanne, Suíça, 1011
- Concluído
- Centre Hospitalier Universitaire Vaudois CHUV
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Nipocalimab
Maternal participants will receive nipocalimab Intravenously (IV). |
Nipocalimab will be administered intravenously.
Outros nomes:
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Comparador de Placebo: Placebo
Maternal participants will receive placebo IV. |
Placebo will be administered intravenously. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Prazo: Up to 1 week post birth
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Neonate/Fetus With Adjudicated Bleeding
Prazo: Up to 1 Week post birth
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Neonate/fetus With adjudicated bleeding will be reported. |
Up to 1 Week post birth
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Platelet Count at Birth in a Neonate
Prazo: At birth
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Platelet count at birth in a neonate will be reported. |
At birth
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Neonate/Fetus with Outcome of Death
Prazo: Up to 1 Week post birth
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Fetus/neonate with outcome of death will be reported. |
Up to 1 Week post birth
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Platelet Count at Birth <10×10^9/L in a Neonate
Prazo: At birth
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Platelet count at birth <10×10^9/L in a neonate will be reported. |
At birth
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Platelet Count at Birth <30×10^9/ L In a Neonate
Prazo: At birth
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Platelet count at birth <30×10^9/L in a neonate will be reported. |
At birth
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Platelet Count at Birth <50×10^9/L In a Neonate
Prazo: At birth
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Platelet count at birth <50×10^9/L in a neonate will be reported. |
At birth
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Platelet Count at Birth <150×10^9/L In a Neonate
Prazo: At birth
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Platelet count at birth <150×10^9/L in a neonate will be reported. |
At birth
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Nadir Platelet Count of a Neonate Over the First Week Post Birth
Prazo: Upto 1 Week post birth
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Nadir platelet count in a neonate will be reported. |
Upto 1 Week post birth
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Neonate/Fetus Requiring Platelet Transfusion(s)
Prazo: Up to 1 Week post birth
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Neonate(s) who require at least one platelet transfusion(s) will be reported. |
Up to 1 Week post birth
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Number of Platelet Transfusion(s) in Neonate/Fetus
Prazo: Up to 1 Week post birth
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Number of Platelet transfusion(s) per neonate will be reported. |
Up to 1 Week post birth
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Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus
Prazo: Up to 1 Week post birth
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Number of donor exposures for neonates who received platelet transfusion(s) will be reported. |
Up to 1 Week post birth
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Neonate/Fetus With Adjudicated Severe Bleeding
Prazo: Up to 1 week post birth
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Neonate/Fetus With adjudicated severe bleeding will be reported. |
Up to 1 week post birth
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Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia
Prazo: Up to 1 Week post birth
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Neonates with IVIG for the treatment of thrombocytopenia will be reported. |
Up to 1 Week post birth
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Maternal Participants With Treatment-Emergent Adverse Event (TEAE)
Prazo: From randomization up to 24 weeks postpartum
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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. |
From randomization up to 24 weeks postpartum
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Maternal Participants With Serious Adverse Event (SAE)
Prazo: From randomization up to 24 weeks postpartum
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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. |
From randomization up to 24 weeks postpartum
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Maternal Participants With Adverse Event of Special Interest (AESI)
Prazo: From randomization up to 24 weeks postpartum
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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. |
From randomization up to 24 weeks postpartum
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Maternal Participants with TEAE Leading to Discontinuation of Study Intervention
Prazo: Up to Week 104
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Maternal participants with TEAE leading to discontinuation of study intervention will be reported. |
Up to Week 104
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Neonate/Infant with TEAE
Prazo: Up to Week 104
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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. |
Up to Week 104
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Neonate/Infant with SAE
Prazo: Up to Week 104
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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. |
Up to Week 104
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Neonate/Infant with AESI
Prazo: Up to Week 104
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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. |
Up to Week 104
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Fetus/Neonate With TEAE of Bleeding
Prazo: Up to Week 104
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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. |
Up to Week 104
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Neonate With TEAE of Infection
Prazo: Up to Week 104
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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. |
Up to Week 104
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Infant Development as Measured by Bayley Scales at Week 52 and Week 104
Prazo: At Week 52 and 104
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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. |
At Week 52 and 104
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Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum
Prazo: Up to Week 24
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Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported. |
Up to Week 24
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicações e links úteis
Publicações Gerais
- 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.
- Baker P, Keshinro B, Stegmann B, Oey A, Shu C, Heerwegh D, Zaha R, Van Valkenburgh H. Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(9):1256-1263. doi: 10.1055/a-2761-1775. Epub 2025 Dec 29.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 80202135FNAIT3001
- 80202135FNAIT3001 (Outro identificador: Janssen Research & Development, LLC)
- 2023-504307-88-00 (Identificador de registro: EUCT number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
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