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En undersøgelse af Nipocalimab til at reducere risikoen for føtal og neonatal alloimmun trombocytopeni (FNAIT) (FREESIA-1)

2. november 2026 opdateret af: Janssen Research & Development, LLC

Dobbeltblind, randomiseret, placebokontrolleret undersøgelse, der evaluerer sikkerheden og effektiviteten af ​​Nipocalimab til at reducere risikoen for føtal og neonatal alloimmun trombocytopeni (FNAIT) i risikograviditeter

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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

39

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Nipocalimab

Maternal participants will receive nipocalimab Intravenously (IV).

Nipocalimab will be administered intravenously.

Andre navne:
  • JNJ-80202135
  • JNJ-86507083
Placebo komparator: Placebo

Maternal participants will receive placebo IV.

Placebo will be administered intravenously.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neonate/Fetus With Adjudicated Bleeding
Tidsramme: 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
Tidsramme: At birth

Platelet count at birth in a neonate will be reported.

At birth
Neonate/Fetus with Outcome of Death
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. november 2024

Primær færdiggørelse (Anslået)

5. december 2029

Studieafslutning (Anslået)

5. december 2029

Datoer for studieregistrering

Først indsendt

4. juni 2024

Først indsendt, der opfyldte QC-kriterier

4. juni 2024

Først opslået (Faktiske)

10. juni 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 80202135FNAIT3001
  • 80202135FNAIT3001 (Anden identifikator: Janssen Research & Development, LLC)
  • 2023-504307-88-00 (Registry Identifier: EUCT number)
  • 2023 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .