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Uno studio su nipocalimab nelle gravidanze a rischio di malattia emolitica grave del feto e del neonato (HDFN) (AZALEA)

2 novembre 2026 aggiornato da: Janssen Research & Development, LLC

Uno studio di fase 3 randomizzato, controllato con placebo, in doppio cieco, multicentrico per valutare l'efficacia e la sicurezza di nipocalimab nelle gravidanze a rischio di malattia emolitica grave del feto e del neonato (HDFN)

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, C1199
        • Reclutamento
        • Hospital Italiano de Buenos Aires
      • Córdoba, Argentina, X5016KEH
        • Reclutamento
        • Hospital Privado Universitario De Cordoba
  • Australia
      • South Brisbane, Australia, 4101
        • Reclutamento
        • Mater Hospital Brisbane
      • Sydney, Australia, 2170
        • Reclutamento
        • Liverpool Hospital
  • Austria
      • Graz, Austria, 8036
        • Reclutamento
        • Medizinische Universitaet Graz
      • Vienna, Austria, 1090
        • Reclutamento
        • Medizinische Universitaet Wien
  • Belgio
      • Brussels, Belgio, 1020
        • Reclutamento
        • C.H.U. Brugmann
      • Leuven, Belgio, 3000
        • Reclutamento
        • Universitair Ziekenhuis Leuven
  • Brasile
      • Belo Horizonte, Brasile, 30130 100
        • Reclutamento
        • Faculdade de Medicina Universidade Federal de Minas Gerais
      • Goiânia, Brasile, 74605 020
        • Reclutamento
        • Hospital das Clinicas - UFG
      • Recife, Brasile, 50070902
        • Reclutamento
        • Instituto de Medicina Integral Professor Fernando Figueira
      • Rio de Janeiro, Brasile, 22281 100
        • Reclutamento
        • IDOR - Regional Rio de Janeiro
      • São Paulo, Brasile, 05403-010
        • Reclutamento
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • Reclutamento
        • BC Women's Hospital University of British Columbia
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Reclutamento
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Reclutamento
        • McGill University Health Centre
      • Montreal, Quebec, Canada, H3T 1C5
        • Reclutamento
        • Centre Hospitalier Sainte Justine
  • Francia
      • Bron, Francia, 69500
        • Reclutamento
        • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
      • Lille, Francia, 59000
        • Reclutamento
        • CHRU Lille
      • Paris, Francia, 75012
        • Reclutamento
        • Hopital Armand Trousseau
  • Germania
      • Berlin, Germania, 10117
        • Reclutamento
        • Charite Universitaetsmedizin Berlin
      • Giessen, Germania, 35392
        • Reclutamento
        • Universitaetsklinikum Giessen und Marburg Standort Giessen
      • Hamburg, Germania, 20251
        • Reclutamento
        • Universitaetsklinikum Hamburg Eppendorf
  • Giappone
      • Fukuoka, Giappone, 812 8582
        • Completato
        • Kyushu University Hospital
      • Gifu, Giappone, 500-8717
        • Reclutamento
        • Gifu Prefectural General Medical Center
      • Izumi-shi, Giappone, 594-1101
        • Reclutamento
        • Osaka Womens and Childrens Hospital
      • Sendai, Giappone, 989-3126
        • Completato
        • Miyagi Childrens Hospital
      • Ōta-ku, Giappone, 143-8541
        • Reclutamento
        • Toho University Medical Center Omori Hospital
  • Irlanda
      • Dublin, Irlanda, D01 P5W9
        • Reclutamento
        • Rotunda Hospital
  • Israele
      • Jerusalem, Israele, 91240
        • Reclutamento
        • Hadassah mount scopus
      • Petah Tikva, Israele, 49100
        • Reclutamento
        • Rabin Medical Center
      • Ramat Gan, Israele, 5265601
        • Reclutamento
        • The Chaim Sheba Medical Center
  • Italia
      • Roma, Italia, 00168
        • Reclutamento
        • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Olanda
      • Leiden, Olanda, 2333 ZA
        • Reclutamento
        • Leiden University Medical Center
  • Polonia
      • Lodz, Polonia, 93 338
        • Reclutamento
        • Instytut Centrum Zdrowia Matki Polki
      • Warsaw, Polonia, 01 211
        • Reclutamento
        • Instytut Matki i Dziecka
      • Warsaw, Polonia, 02 507
        • Reclutamento
        • Panstwowy Instytut Medyczny MSWiA w Warszawie
  • Regno Unito
      • Birmingham, Regno Unito, B15 2TG
        • Reclutamento
        • Birmingham Women's Hospital
      • Leeds, Regno Unito, LS9 7TF
        • Reclutamento
        • Leeds Teaching Hospitals NHS Trust
      • London, Regno Unito, SE5 9RS
        • Reclutamento
        • Kings College Hospital
      • London, Regno Unito, SW17 0QT
        • Reclutamento
        • St Georges Hospital
      • Manchester, Regno Unito, M13 9WL
        • Reclutamento
        • St.Mary's Hospital
      • Oxford, Regno Unito, OX3 9DU
        • Reclutamento
        • John Radcliffe Hospital
  • Spagna
      • Barcelona, Spagna, 08035
        • Reclutamento
        • Hosp Univ Vall D Hebron
      • Madrid, Spagna, 28046
        • Reclutamento
        • Hosp. Univ. La Paz
      • Seville, Spagna, 41013
        • Reclutamento
        • Hosp. Virgen Del Rocio
  • Stati Uniti
    • California
      • La Jolla, California, Stati Uniti, 92037
        • Reclutamento
        • University of California at San Diego
      • Los Angeles, California, Stati Uniti, 90027
        • Reclutamento
        • Kaiser Permanente Los Angeles Medical Center
      • Sacramento, California, Stati Uniti, 95817
        • Reclutamento
        • UC Davis School of Medicine
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Reclutamento
        • Childrens Hospital Colorado
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • Reclutamento
        • University of Miami
    • Illinois
      • Park Ridge, Illinois, Stati Uniti, 60068
        • Reclutamento
        • Advocate Children's Hospital
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Sospeso
        • Riley Children s Hospital
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • Reclutamento
        • University of Iowa
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536
        • Reclutamento
        • University of Kentucky Medical Center
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • Reclutamento
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Reclutamento
        • Boston Childrens Hospital
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55404
        • Reclutamento
        • Midwest Fetal Care Center
    • New York
      • New York, New York, Stati Uniti, 10032
        • Reclutamento
        • Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7516
        • Reclutamento
        • University of North Carolina (UNC) - School of Medicine
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267
        • Reclutamento
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Reclutamento
        • Oregon Health and Science University
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti, 18103-6218
        • Reclutamento
        • Lehigh Valley Hospital
    • Texas
      • Austin, Texas, Stati Uniti, 78723
        • Reclutamento
        • University of Texas Dell Medical School Department of Women's Health
      • Galveston, Texas, Stati Uniti, 77555
        • Reclutamento
        • University Of Texas Medical Branch At Galveston
    • Utah
      • Murray, Utah, Stati Uniti, 84107
        • Reclutamento
        • Intermountain Medical Center
    • Virginia
      • Norfolk, Virginia, Stati Uniti, 23507
        • Reclutamento
        • Macon & Joan Brock Virginia Health Sciences at Old Dominion University
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • Reclutamento
        • Seattle Children's Hospital
  • Svezia
      • Stockholm, Svezia, 14186
        • Reclutamento
        • Karolinska Universitetssjukhuset Huddinge

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13^0/7 to Week 18^6/7 at randomization

  • History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented:

    1. fetal anemia as result of HDFN or fetal hydrops as result of HDFN or received greater than or equal to (>=)1 IUT as a result of HDFN or
    2. fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for Rhesus antigen D protein (RhD), Kell, Kell Rhesus antigen C protein (Rhc), Rhesus antigen E protein (RhE), or RhC antigen above the critical levels (anti-Kell >=4; other >=16) and evidence of an antigen-positive fetus

  • During the current pregnancy, presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above the critical level (anti-Kell >= 4; other >=16) based on the designated central lab results at screening

  • Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cell-free fetal DNA (cffDNA) performed at the central laboratory

  • Have screening lab test results within values within the study protocol-specified parameters: a) albumin >= lower limit of normal (LLN); b) alanine transaminase (AST) less than or equal to (<=) 2 × upper limit of normal (ULN); c) alanine transaminase (ALT) <=2 × ULN d) creatinine <=0.8 milligrams per deciliter (mg/dL), SI: <=70.7 micromole per liter (μmol/L), and Serum total immunoglobulins G (IgG) ≥ 600 mg/dL SI: >=6 g/L

  • Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical lab tests performed at screening

Exclusion Criteria:

  • Currently pregnant with a multiple gestation (twins or more)
  • Evidence of fetal anemia prior to randomization in the current pregnancy
  • History of severe preeclampsia prior to GA Week 34 or severe fetal growth restriction (estimated fetal weight <3rd percentile, based on local fetal growth normative standards) in a previous pregnancy
  • Current uncontrolled hypertension
  • History of myocardial infarction, unstable ischemic heart disease, or stroke
  • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
  • Has inflammatory or autoimmune diseases requiring immunosuppressive therapies that may jeopardize the safety of the participant
  • Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention)
  • Is currently receiving systemic corticosteroids or other immunosuppressants for disorders unrelated to the pregnancy
  • Has received or planning to receive plasmapheresis, immunoadsorption therapy, intravenous immunoglobulin (IV Ig), or any immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics during the current pregnancy
  • Has a severe infection including opportunistic infections
  • Presence of abnormal (protocol-specified) hematologic lab values during screening
  • History of an unprovoked pulmonary embolism or history of recurrent deep vein thrombosis (DVT)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nipocalimab

Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
Droga: Nipocalimab

Nipocalimab will be administered as an intravenous infusion.

Altri nomi:
  • JNJ-80202135
  • M281
  • JNJ-86507083
Comparatore placebo: Placebo

Participants will receive matching placebo IV qw from randomization through GA Week 35.
Droga: Placebo

Placebo will be administered as an intravenous infusion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Lasso di tempo: From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later

Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death (during the neonatal period) will be reported. Hydrops fetalis is defined as the presence of greater than or equal to(>=)2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater (>)5 millimeter [mm]). PMA is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).
From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Lasso di tempo: For first database lock: from randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later for the first database lock; for second database lock: through 12 weeks after birth

Number of participants with HDFN by severity will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. Here database lock implies the last participant has given birth or terminated their pregnancy, completed the Week 4 visit after delivery, and whose neonate has also completed the Week 4 visit (or 41 weeks PMA, whichever is later) or died prior to this timepoint.
For first database lock: from randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later for the first database lock; for second database lock: through 12 weeks after birth
Time to First Occurrence of IUT or Hydrops Fetalis
Lasso di tempo: From randomization to delivery of baby (Up to 38 weeks)

Time to first occurrence of IUT or hydrops fetalis will be reported.
From randomization to delivery of baby (Up to 38 weeks)
Neonatal Mortality and Morbidity Index (NMMI) in Liveborn Neonates
Lasso di tempo: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA

The NMMI will be assessed with the following categories: fatal: fetal/neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category'
Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA
Number of IUT's Received During the Pregnancy
Lasso di tempo: From randomization to delivery of baby (Up to 38 weeks)

Number of IUT's received during the pregnancy will be reported.
From randomization to delivery of baby (Up to 38 weeks)
Percentage of Pregnancies With Fetal Loss
Lasso di tempo: Time to delivery of baby (Up to 38 weeks)

Percentage of pregnancies with fetal loss will be reported.
Time to delivery of baby (Up to 38 weeks)
Percentage of Pregnancies With Fetal or Neonatal Death
Lasso di tempo: Through Week 4 or 41 weeks PMA

Percentage of pregnancies with fetal or neonatal death (through the neonatal period) as a result of HDFN will be reported.
Through Week 4 or 41 weeks PMA
Percentage of Pregnancies With Hydrops Fetalis
Lasso di tempo: Up to 41 weeks PMA

Percentage of pregnancies with hydrops fetalis will be reported. Hydrops fetalis is defined as the presence of >=2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness >5 mm).
Up to 41 weeks PMA
Percentage of Pregnancies Receiving IUT During Pregnancy
Lasso di tempo: Up to 35 weeks of GA period

Percentage of pregnancies receiving IUT during pregnancy will be reported.
Up to 35 weeks of GA period
Gestational Age (GA) at First IUT
Lasso di tempo: Up to 35 weeks of GA period

GA at first IUT will be reported.
Up to 35 weeks of GA period
Percentage of Pregnancies Receiving >1 IUT During Pregnancy
Lasso di tempo: Up to 35 weeks of GA period

Percentage of pregnancies receiving >1 IUT during pregnancy will be reported.
Up to 35 weeks of GA period
Percentage of Pregnancies Receiving IUT or HDFN Resulting in Fetal Demise (Less Than) <GA Week 20
Lasso di tempo: Up to 20 weeks

Percentage of pregnancies receiving IUT or HDFN resulting in fetal demise <GA Week 20 will be reported.
Up to 20 weeks
Gestational Age at Delivery
Lasso di tempo: Up to 38 weeks

Gestational age at delivery will be reported.
Up to 38 weeks
Percentage of Pregnancies With Neonatal Death Through the Neonatal Period
Lasso di tempo: From randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later

Percentage of pregnancies with neonatal death through the neonatal period will be reported.
From randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later
Percentage of Liveborn Neonates With HDFN-related Morbidities Other Than Anemia and Hyperbilirubinemia or Jaundice
Lasso di tempo: From day of birth up to 4 weeks

Percentage of liveborn neonates with HDFN-related morbidities other than anemia and hyperbilirubinemia or jaundice will be reported.
From day of birth up to 4 weeks
Absolute Weight of Liveborn Neonates or Infants
Lasso di tempo: Up to 104 weeks

Absolute weight of liveborn neonates or infants will be reported.
Up to 104 weeks
Change From Baseline in Weight of Liveborn Neonates or Infants
Lasso di tempo: Baseline to up to 104 weeks

Change from baseline in weight of liveborn neonates or infants will be reported.
Baseline to up to 104 weeks
Liveborn Neonates Length of Stay in Neonatal Intensive Care Unit
Lasso di tempo: From day of birth up to 27 days

Liveborn neonates length of stay in neonatal intensive care unit will be reported.
From day of birth up to 27 days
Percentage of Liveborn Neonates Receiving Exchange Transfusions for HDFN
Lasso di tempo: From day of birth up to 27 days

Percentage of liveborn neonates receiving exchange transfusions for HDFN will be reported.
From day of birth up to 27 days
Number of Neonatal Exchange Transfusions per Liveborn Neonate
Lasso di tempo: From day of birth up to 27 days

Number of neonatal exchange transfusions per liveborn neonate will be reported.
From day of birth up to 27 days
Percentage of Liveborn Neonates or Infants with Simple Transfusions for HDFN
Lasso di tempo: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks

Percentage of liveborn neonates or infants with simple transfusions for HDFN through the neonatal period (for the first database lock) or 12 weeks (for the second database lock) after birth will be reported.
For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Number of Simple Transfusions for HDFN per Liveborn Neonate or Infant
Lasso di tempo: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks

Number of simple transfusions for HDFN per liveborn neonate or infant through the neonatal period (for the first database lock) or 12 weeks (for the second database lock) after birth will be reported.
For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Percentage of Liveborn Neonates With Hyperbilirubinemia Treated With Phototherapy
Lasso di tempo: From day of birth up to 27 days

Percentage of liveborn neonates with hyperbilirubinemia treated with phototherapy will be reported.
From day of birth up to 27 days
Number of Days of Phototherapy Received for Hyperbilirubinemia per Liveborn Neonate
Lasso di tempo: From day of birth up to 27 days

Number of days of phototherapy received for hyperbilirubinemia per liveborn neonate will be reported.
From day of birth up to 27 days
Percentage of Liveborn Neonates or Infants Receiving Intravenous Immunoglobulin (IVIg) for HDFN Treatment
Lasso di tempo: For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks

Percentage of liveborn neonates or infants receiving IVIg for HDFN treatment will be reported.
For first database lock: From birth up to 4 weeks; for second database lock: From birth up to 12 weeks
Number of Maternal Deaths
Lasso di tempo: Form randomization up to 24 weeks postpartum

Number of maternal deaths will be reported.
Form randomization up to 24 weeks postpartum
Number of Participants with Adverse Events (AEs)
Lasso di tempo: From randomization up to 24 weeks postpartum

Number of participants with AEs, serious adverse events, and AEs of special interest (AESIs), AE's leading to discontinuations, infections, serious infections, infusion reactions, and hypersensitivity reactions will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: hypoalbuminemia, clinically significant bleeding with a corresponding placental finding on ultrasound, maternal infections that led to clinically significant morbidities or mortalities in fetus or neonates, Infections that are severe or require intravenous (IV) anti-infective or operative or invasive intervention in maternal participants or neonates or infants, and infants with hypogammaglobulinemia.
From randomization up to 24 weeks postpartum
Number of Maternal Pregnancy Complications
Lasso di tempo: Up to 38 weeks

Number of maternal pregnancy complications will be reported.
Up to 38 weeks
Number of IUT Related complications
Lasso di tempo: Up to 35 weeks of GA period

Number of participants with IUT related complications will be reported.
Up to 35 weeks of GA period
Percentage of Pregnancies With Cesarean Delivery, Preterm Birth, Fetal Growth, and Preeclampsia
Lasso di tempo: Up to 38 weeks of GA period

Percentage of pregnancies with cesarean delivery, cesarean delivery due to IUT complications, preterm birth <GA week 28, preterm birth <GA week 32, preterm birth <GA week 34, preterm birth <GA week 37, fetal growth restriction, and preeclampsia will be reported.
Up to 38 weeks of GA period
Percentage of Liveborn Neonates or Infants Who Died
Lasso di tempo: Up to 104 weeks

Percentage of liveborn neonates or infants who died will be reported.
Up to 104 weeks
Percentage of Liveborn Neonates or Infants With AEs
Lasso di tempo: Up to 104 weeks

Percentage of liveborn neonates or infants with AEs, SAEs, AESIs, infections, serious infections will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. Any event requiring hospitalization (or prolongation of hospitalization) that occurs during participation in the study must be reported as an SAE.
Up to 104 weeks
Percentage of Liveborn Neonates or Infants Receiving IVIg for Non-HDFN Indications
Lasso di tempo: Up to 104 weeks

Percentage of liveborn neonates or infants receiving IVIg for non-HDFN indications will be reported.
Up to 104 weeks
Percentage of Liveborn Neonates or Infants With Abnormal Hearing
Lasso di tempo: Up to 104 weeks

Percentage of liveborn neonates or infants with abnormal hearing will be reported.
Up to 104 weeks
Bayley Scales of Infant Development and Toddler Development
Lasso di tempo: Week 52 and 104

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 (3rd edition) 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.
Week 52 and 104
Change From Baseline in Generalized Anxiety Disorder 7-Item (GAD7) Over time During Pregnancy and Postpartum
Lasso di tempo: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in GAD7 over time during pregnancy and postpartum will be reported. The GAD-7 scale is a self-administered questionnaire designed to measure anxiety. The recall period for all items is the past 2 weeks. Responses to all items are rated on a 4-point Likert scale ranging from 0 "not at all" to 3 "nearly every day". The total score ranges from 0 to 21, with higher scores indicating higher severity of anxiety symptoms.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
Lasso di tempo: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in SF-36v2 acute form domain score will be reported. The SF-36 version 2 acute is a self-administered, 36-item questionnaire measuring health-related quality of life and includes 8 domains that measure physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality social functioning, role limitations due to emotional problems, and mental health. The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary and a mental component summary. Responses to all items are rated on a 3, 5, or 6-point Likert scale, with higher scores indicating better health status.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in EuroQol Five-dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Lasso di tempo: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in EQ-5D-5L visual analogue score will be reported. The EQ-5D descriptive system is comprised of 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. The EQ-5D-5L uses a 5-point Likert response scale ranging from "no problems" to "extreme problems", with higher scores indicating better quality of life. EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS). EQ-VAS score ranges from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Higher score indicates good health state.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Change From Baseline in EuroQol 5-Dimension Descriptive (EQ-5D) Index Score
Lasso di tempo: Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum

Change from baseline in EQ-5D index score will be reported. The EQ-5D descriptive system is comprised of 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety or depression. The EQ-5D-5L descriptive system uses a 5-point Likert response scale ranging from "no problems" to "extreme problems", with higher scores indicating better quality of life.
Baseline (Day 1) and Week 30 during pregnancy and Week 4 postpartum
Infant Health-Related Quality of Life Instrument (IQI) Score for Neonate or Infant Overtime
Lasso di tempo: Weeks 4, 8 and 52

IQI score for neonate or infant will be reported. The IQI consists of 7 health attributes including sleeping, feeding, breathing, stooling or poo, mood, skin, and interaction. Responses to all items are rated on a 4-point Likert scale, with higher scores indicating better quality of life.
Weeks 4, 8 and 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 dicembre 2023

Completamento primario (Stimato)

5 agosto 2027

Completamento dello studio (Stimato)

8 ottobre 2029

Date di iscrizione allo studio

Primo inviato

13 giugno 2023

Primo inviato che soddisfa i criteri di controllo qualità

13 giugno 2023

Primo Inserito (Effettivo)

22 giugno 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CR109199
  • 2021-002359-12 (Numero EudraCT)
  • 80202135EBF3001 (Altro identificatore: Janssen Research & Development, LLC)
  • 2022-502629-16-00 (Identificatore di registro: EUCT number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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