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Eine Studie zu Nipocalimab bei Schwangerschaften mit dem Risiko einer schweren hämolytischen Erkrankung des Fötus und Neugeborenen (HDFN) (AZALEA)

2. November 2026 aktualisiert von: Janssen Research & Development, LLC

Eine randomisierte, placebokontrollierte, doppelblinde, multizentrische Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Nipocalimab bei Schwangerschaften mit dem Risiko einer schweren hämolytischen Erkrankung des Fötus und Neugeborenen (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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Nipocalimab

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

Nipocalimab will be administered as an intravenous infusion.

Andere Namen:
  • JNJ-80202135
  • M281
  • JNJ-86507083
Placebo-Komparator: Placebo

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

Placebo will be administered as an intravenous infusion.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Up to 38 weeks

Number of maternal pregnancy complications will be reported.
Up to 38 weeks
Number of IUT Related complications
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Research & Development, LLC

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Dezember 2023

Primärer Abschluss (Geschätzt)

5. August 2027

Studienabschluss (Geschätzt)

8. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

13. Juni 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juni 2023

Zuerst gepostet (Tatsächlich)

22. Juni 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • CR109199
  • 2021-002359-12 (EudraCT-Nummer)
  • 80202135EBF3001 (Andere Kennung: Janssen Research & Development, LLC)
  • 2022-502629-16-00 (Registrierungskennung: EUCT number)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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