En studie av Nipocalimab eller intravenøst immunoglobulin (IVIG) i graviditeter med risiko for føtal og neonatal alloimmun trombocytopeni (FNAIT) (FREESIA-3)
Multisenter, åpen etikett, randomisert studie av nipocalimab eller intravenøst immunoglobulin (IVIG) i svangerskap med risiko for føtal og neonatal alloimmun trombocytopeni (FNAIT)
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).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Leuven, Belgia, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Rekruttering
- The University of Alabama at Birmingham
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California
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Sacramento, California, Forente stater, 95817
- Rekruttering
- UC Davis School of Medicine
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- Childrens Hospital Colorado
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Florida
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Gainesville, Florida, Forente stater, 32611
- Rekruttering
- University of Florida at Shands
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Illinois
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Park Ridge, Illinois, Forente stater, 60068
- Rekruttering
- Advocate Children's Hospital
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Suspendert
- Riley Children s Hospital
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Hospital and Clinics
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Rekruttering
- Wayne State University
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New York
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Rochester, New York, Forente stater, 14642
- Rekruttering
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill
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Ohio
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Cincinnati, Ohio, Forente stater, 45267
- Rekruttering
- University of Cincinnati
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Texas
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Galveston, Texas, Forente stater, 77555
- Rekruttering
- University of Texas Medical Branch
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Utah
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Salt Lake City, Utah, Forente stater, 84108
- Rekruttering
- University of Utah
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Ramat Gan, Israel, 5262000
- Rekruttering
- Sheba Medical Center
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Milan, Italia, 20122
- Rekruttering
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Leiden, Nederland, 2333 ZA
- Rekruttering
- Leiden University Medical Center
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Lodz, Polen, 93 338
- Rekruttering
- Instytut Centrum Zdrowia Matki Polki
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Warsaw, Polen, 01 211
- Rekruttering
- Instytut Matki i Dziecka
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Warsaw, Polen, 02 507
- Rekruttering
- Panstwowy Instytut Medyczny MSWiA w Warszawie
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Košice, Slovakia, 040 11
- Rekruttering
- Univerzitna nemocnica L. Pasteura Kosice
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Nové Zámky, Slovakia, 940 34
- Rekruttering
- Fakultna nemocnica s poliklinikou Nove Zamky
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Ljubljana, Slovenia, 1000
- Rekruttering
- Univerzitetni klinicni center Ljubljana
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Birmingham, Storbritannia, B15 2TG
- Rekruttering
- Birmingham Women's Hospital
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Liverpool, Storbritannia, L8 7SS
- Rekruttering
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
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London, Storbritannia, W12 0HS
- Rekruttering
- Queen Charlotte's and Chelsea Hospital
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Oxford, Storbritannia, OX3 9DU
- Rekruttering
- John Radcliffe Hospital
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Berlin, Tyskland, 10117
- Rekruttering
- Charite Universitaetsmedizin Berlin
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Giessen, Tyskland, 35392
- Rekruttering
- Universitaetsklinikum Giessen und Marburg GmbH
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Hanover, Tyskland, 30625
- Rekruttering
- Medizinische Hochschule Hannover
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Jena, Tyskland, 07747
- Rekruttering
- Universitatsklinikum Jena
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Tübingen, Tyskland, 72076
- Rekruttering
- Universitaetsklinikum Tuebingen
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Graz, Østerrike, 8036
- Rekruttering
- Medizinische Universitaet Graz
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Vienna, Østerrike, 1090
- Rekruttering
- Medical University Vienna
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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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
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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)
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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
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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
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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, to IVIG or to prednisone that would preclude treatment
- 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Arm 1: Nipocalimab
Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery. |
Nipocalimab will be administered intravenously.
Andre navn:
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Eksperimentell: Arm 2: Intravenous Immunoglobins (IVIG)
Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance. |
IVIG will be administered intravenously. Prednisone will be administered orally. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Platelet Count at Birth in a Neonate
Tidsramme: 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
Tidsramme: 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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Neonate with Platelet Count at Birth <10*10^9/L
Tidsramme: 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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Neonate with Platelet Count at Birth <30*10^9/L
Tidsramme: 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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Neonate with Platelet Count at Birth <50*10^9/L
Tidsramme: 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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Neonate with Platelet Count at Birth <150*10^9/L
Tidsramme: 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 in a Neonate
Tidsramme: Up to 1 Week post birth
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Nadir platelet count in a neonate will be reported. |
Up to 1 Week post birth
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Neonate Requiring Platelet Transfusion
Tidsramme: Up to 1 Week post birth
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Neonate who require at least one platelet transfusion will be reported. |
Up to 1 Week post birth
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Number of Platelet Transfusions in Neonate
Tidsramme: Up to 1 Week post birth
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Number of platelet transfusions per neonate will be reported. |
Up to 1 Week post birth
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Number of Donor Exposures for Platelet Transfusions in Neonate
Tidsramme: Up to 1 Week post birth
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Number of donor exposures for a neonate who received at least one platelet transfusion will be reported. |
Up to 1 Week post birth
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Neonate/Fetus With Adjudicated Bleeding
Tidsramme: 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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Neonate Requiring Postnatal Intravenous Immunoglobulin (IVIG) for the Treatment of Thrombocytopenia
Tidsramme: Up to 1 Week post birth
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Neonate requiring IVIG for the treatment of thrombocytopenia will be reported. |
Up to 1 Week post birth
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Maternal Participant with Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and Adverse Event of Special Interest (AESI)
Tidsramme: Up to Week 24
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Maternal participant with TEAE, SAE and 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. |
Up to Week 24
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Maternal Participant with TEAE Leading to Discontinuation of Study Intervention
Tidsramme: Up to Week 24
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Maternal participant with TEAE leading to discontinuation of study intervention will be reported. |
Up to Week 24
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Neonate/Infant With TEAE, SAE and AESI
Tidsramme: From Day of birth to Week 104
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Neonate/infant with TEAE, SAE and AESI 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. |
From Day of birth to Week 104
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Fetus/Neonate with a TEAE of Bleeding
Tidsramme: From Day of birth to Week 104
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Fetus/Neonate with a TEAE of bleeding will be reported. |
From Day of birth to Week 104
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Neonate with a TEAE of Infection
Tidsramme: From Day of birth to Week 104
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Neonate with a TEAE of infection will be reported. |
From Day of birth to Week 104
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Bayley Scales Assessment for Infant Development
Tidsramme: At Week 52 and Week 104
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The Bayley Scales of infant development is considered the standard assessment of early child development and includes cognition, language, motor skills, social emotional, and adaptive behavior will be reported. The Bayley Scales are reference standards that measure infant and toddler development in five areas: cognition, language, motor skills, social-emotional and adaptive behavior. The cognition, language and 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. Higher scores in the Bayley Scales indicate better outcomes. |
At Week 52 and Week 104
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Maternal Participants with Incidence of Antibodies to Nipocalimab
Tidsramme: Up to Week 4
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Incidence of antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported. |
Up to Week 4
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Cytopeni
- Spedbarn, nyfødte, sykdommer
- Hematologiske sykdommer
- Blodplateforstyrrelser
- Trombocytopeni
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Hemic og lymfatiske sykdommer
- Trombocytopeni, neonatal alloimmun
- Aminosyrer, peptider og proteiner
- Proteiner
- Polysykliske forbindelser
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Gravadienedioler
- Immunoglobulinisotyper
- Immunoglobulin G.
- Prednison
- Immunglobuliner, intravenøst
Andre studie-ID-numre
- 80202135FNAIT3003
- 2023-509434-19-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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
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