En undersøgelse af nipocalimab eller intravenøst immunglobulin (IVIG) i graviditeter med risiko for føtal og neonatal alloimmun trombocytopeni (FNAIT) (FREESIA-3)
Multicenter, open-label, randomiseret undersøgelse af nipocalimab eller intravenøst immunglobulin (IVIG) i graviditeter 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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Leuven, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Birmingham, Det Forenede Kongerige, B15 2TG
- Rekruttering
- Birmingham Women's Hospital
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Liverpool, Det Forenede Kongerige, L8 7SS
- Rekruttering
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
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London, Det Forenede Kongerige, W12 0HS
- Rekruttering
- Queen Charlotte's and Chelsea Hospital
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Oxford, Det Forenede Kongerige, OX3 9DU
- Rekruttering
- John Radcliffe Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- Rekruttering
- The University of Alabama at Birmingham
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California
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Sacramento, California, Forenede Stater, 95817
- Rekruttering
- UC Davis School of Medicine
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Childrens Hospital Colorado
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Florida
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Gainesville, Florida, Forenede Stater, 32611
- Rekruttering
- University of Florida at Shands
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Illinois
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Park Ridge, Illinois, Forenede Stater, 60068
- Rekruttering
- Advocate Children's Hospital
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Suspenderet
- Riley Children s Hospital
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa Hospital and Clinics
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Rekruttering
- Wayne State University
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New York
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Rochester, New York, Forenede Stater, 14642
- Rekruttering
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- University of North Carolina at Chapel Hill
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
- Rekruttering
- University of Cincinnati
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Texas
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Galveston, Texas, Forenede Stater, 77555
- Rekruttering
- University of Texas Medical Branch
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Utah
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Salt Lake City, Utah, Forenede Stater, 84108
- Rekruttering
- University of Utah
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Leiden, Holland, 2333 ZA
- Rekruttering
- Leiden University Medical Center
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Ramat Gan, Israel, 5262000
- Rekruttering
- Sheba Medical Center
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Milan, Italien, 20122
- Rekruttering
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario A Gemelli IRCCS
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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, Slovakiet, 040 11
- Rekruttering
- Univerzitna nemocnica L. Pasteura Kosice
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Nové Zámky, Slovakiet, 940 34
- Rekruttering
- Fakultna nemocnica s poliklinikou Nove Zamky
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Ljubljana, Slovenien, 1000
- Rekruttering
- Univerzitetni klinicni center Ljubljana
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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, Østrig, 8036
- Rekruttering
- Medizinische Universitaet Graz
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Vienna, Østrig, 1090
- Rekruttering
- Medical University Vienna
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 navne:
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Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Cytopeni
- Spædbarn, Nyfødt, Sygdomme
- Hæmatologiske sygdomme
- Blodpladeforstyrrelser
- Trombocytopeni
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Hemiske og lymfatiske sygdomme
- Trombocytopeni, neonatal alloimmun
- Aminosyrer, peptider og proteiner
- Proteiner
- Polycykliske forbindelser
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Gravideretioler
- Immunoglobulin -isotyper
- Immunoglobulin g
- Prednison
- Immunglobuliner, intravenøst
Andre undersøgelses-id-numre
- 80202135FNAIT3003
- 2023-509434-19-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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