Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een onderzoek naar nipocalimab bij het verminderen van het risico op foetale en neonatale allo-immune trombocytopenie (FNAIT) (FREESIA-1)

2 november 2026 bijgewerkt door: Janssen Research & Development, LLC

Dubbelblind, gerandomiseerd, placebogecontroleerd onderzoek ter evaluatie van de veiligheid en werkzaamheid van Nipocalimab bij het verminderen van het risico op foetale en neonatale allo-immune trombocytopenie (FNAIT) bij risicovolle zwangerschappen

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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

39

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • België
      • Leuven, België, 3000
        • Voltooid
        • Universitair Ziekenhuis Leuven
  • Brazilië
      • Recife, Brazilië, 50070-902
        • Voltooid
        • Instituto de Medicina Integral Professor Fernando Figueira
      • Rio de Janeiro, Brazilië, 22281 100
        • Voltooid
        • IDOR - Regional Rio de Janeiro
      • São Paulo, Brazilië, 05403 000
        • Voltooid
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Frankrijk
      • Lille, Frankrijk, 59000
        • Voltooid
        • CHRU Lille
      • Paris, Frankrijk, 75012
        • Voltooid
        • Hopital trousseau- APHP
  • Hongarije
      • Budapest, Hongarije, 1082
        • Werving
        • Semmelweis Egyetem
  • Israël
      • Ramat Gan, Israël, 5262000
        • Voltooid
        • Sheba Medical Center
  • Italië
      • Milan, Italië, 20122
        • Voltooid
        • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
      • Rome, Italië, 00168
        • Voltooid
        • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Noorwegen
      • Bergen, Noorwegen, 5009
        • Werving
        • Haukeland University Hospital
      • Oslo, Noorwegen, 0455
        • Werving
        • Oslo University Hospital HF Ulleval sykehus
      • Tromsø, Noorwegen, 9019
        • Werving
        • Universitetssykehuset Nord-Norge HF
      • Trondheim, Noorwegen, 7030
        • Werving
        • St. Olavs Hospital
  • Slovenië
      • Ljubljana, Slovenië, 1000
        • Voltooid
        • Univerzitetni klinicni center Ljubljana
  • Slowakije
      • Košice, Slowakije, 04190
        • Voltooid
        • Univerzitna nemocnica L. Pasteura Kosice
      • Martin, Slowakije, 036 01
        • Voltooid
        • Univerzitná nemocnica Martin
      • Nové Zámky, Slowakije, 940 34
        • Voltooid
        • Fakultna nemocnica s poliklinikou Nove Zamky
  • Spanje
      • Seville, Spanje, 41013
        • Voltooid
        • Hosp. Virgen Del Rocio
  • Zweden
      • Stockholm, Zweden, SE-141 86
        • Werving
        • Karolinska Universitetssjukhuset Huddinge
  • Zwitserland
      • Lausanne, Zwitserland, 1011
        • Voltooid
        • Centre Hospitalier Universitaire Vaudois CHUV

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Nipocalimab

Maternal participants will receive nipocalimab Intravenously (IV).
Geneesmiddel: Nipocalimab

Nipocalimab will be administered intravenously.

Andere namen:
  • JNJ-80202135
  • JNJ-86507083
Placebo-vergelijker: Placebo

Maternal participants will receive placebo IV.
Geneesmiddel: Placebo

Placebo will be administered intravenously.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Tijdsspanne: 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.
Up to 1 week post birth

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Neonate/Fetus With Adjudicated Bleeding
Tijdsspanne: Up to 1 Week post birth

Neonate/fetus With adjudicated bleeding will be reported.
Up to 1 Week post birth
Platelet Count at Birth in a Neonate
Tijdsspanne: At birth

Platelet count at birth in a neonate will be reported.
At birth
Neonate/Fetus with Outcome of Death
Tijdsspanne: Up to 1 Week post birth

Fetus/neonate with outcome of death will be reported.
Up to 1 Week post birth
Platelet Count at Birth <10×10^9/L in a Neonate
Tijdsspanne: At birth

Platelet count at birth <10×10^9/L in a neonate will be reported.
At birth
Platelet Count at Birth <30×10^9/ L In a Neonate
Tijdsspanne: At birth

Platelet count at birth <30×10^9/L in a neonate will be reported.
At birth
Platelet Count at Birth <50×10^9/L In a Neonate
Tijdsspanne: At birth

Platelet count at birth <50×10^9/L in a neonate will be reported.
At birth
Platelet Count at Birth <150×10^9/L In a Neonate
Tijdsspanne: At birth

Platelet count at birth <150×10^9/L in a neonate will be reported.
At birth
Nadir Platelet Count of a Neonate Over the First Week Post Birth
Tijdsspanne: Upto 1 Week post birth

Nadir platelet count in a neonate will be reported.
Upto 1 Week post birth
Neonate/Fetus Requiring Platelet Transfusion(s)
Tijdsspanne: Up to 1 Week post birth

Neonate(s) who require at least one platelet transfusion(s) will be reported.
Up to 1 Week post birth
Number of Platelet Transfusion(s) in Neonate/Fetus
Tijdsspanne: Up to 1 Week post birth

Number of Platelet transfusion(s) per neonate will be reported.
Up to 1 Week post birth
Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus
Tijdsspanne: Up to 1 Week post birth

Number of donor exposures for neonates who received platelet transfusion(s) will be reported.
Up to 1 Week post birth
Neonate/Fetus With Adjudicated Severe Bleeding
Tijdsspanne: Up to 1 week post birth

Neonate/Fetus With adjudicated severe bleeding will be reported.
Up to 1 week post birth
Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia
Tijdsspanne: Up to 1 Week post birth

Neonates with IVIG for the treatment of thrombocytopenia will be reported.
Up to 1 Week post birth
Maternal Participants With Treatment-Emergent Adverse Event (TEAE)
Tijdsspanne: 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.
From randomization up to 24 weeks postpartum
Maternal Participants With Serious Adverse Event (SAE)
Tijdsspanne: 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.
From randomization up to 24 weeks postpartum
Maternal Participants With Adverse Event of Special Interest (AESI)
Tijdsspanne: 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.
From randomization up to 24 weeks postpartum
Maternal Participants with TEAE Leading to Discontinuation of Study Intervention
Tijdsspanne: Up to Week 104

Maternal participants with TEAE leading to discontinuation of study intervention will be reported.
Up to Week 104
Neonate/Infant with TEAE
Tijdsspanne: 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.
Up to Week 104
Neonate/Infant with SAE
Tijdsspanne: 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.
Up to Week 104
Neonate/Infant with AESI
Tijdsspanne: 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.
Up to Week 104
Fetus/Neonate With TEAE of Bleeding
Tijdsspanne: 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.
Up to Week 104
Neonate With TEAE of Infection
Tijdsspanne: 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.
Up to Week 104
Infant Development as Measured by Bayley Scales at Week 52 and Week 104
Tijdsspanne: 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.
At Week 52 and 104
Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum
Tijdsspanne: Up to Week 24

Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.
Up to Week 24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 november 2024

Primaire voltooiing (Geschat)

5 december 2029

Studie voltooiing (Geschat)

5 december 2029

Studieregistratiedata

Eerst ingediend

4 juni 2024

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2024

Eerst geplaatst (Werkelijk)

10 juni 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 80202135FNAIT3001
  • 80202135FNAIT3001 (Andere identificatie: Janssen Research & Development, LLC)
  • 2023-504307-88-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren