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AZALEANCT05912517

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 43 versions: 36 with changes below, 7 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 65 → 69 locations
  2. Eligibility criteria shortened, about 5 words
    • Study sites: 64 to 65
    • Secondary endpoints: details revised at 15 of 39 entries
    • Publications: details revised at 1 of 1 entry
  3. Study sites revised (64)v41
  4. Study sites: 62 to 64v40
  5. Study sites: 61 to 62v38
  6. Study sites: 60 to 61v37
  7. Study completion pushed from Jul 10, 2029 to Oct 8, 2029
    • Study sites: 59 to 60
    v36
  8. Study completion date: Aug 30, 2029 to Jul 10, 2029v35
  9. Study sites: 57 to 59
    • Study completion date: Jul 10, 2029 to Aug 30, 2029
    v34
  10. Site details revised at 1 of 57 sitesv33
  11. Study sites: 56 to 57v32
  12. Study sites: 53 to 56v28
  13. Study sites revised (53)v27
  14. Study sites: 52 to 53v26
  15. Study sites: 49 to 52v25
  16. Eligibility criteria expanded, about 71 words
    • Study sites: 43 to 49
    v24
  17. Study sites: 42 to 43v23
  18. Study sites: 40 to 42v22
  19. Study sites: 32 to 40v20
  20. Study sites: 30 to 32v18
  21. Study sites: 28 to 30v17
  22. Study sites revised (28)v16
  23. Study sites: 19 to 28v15
  24. Study sites: 18 to 19v14
  25. Study sites: 12 to 18v13
  26. Study sites: 10 to 12v12
  27. Study sites: 6 to 10v11
  28. Study sites: 2 to 6v10
  29. Study completion date: Jul 29, 2029 to Jul 10, 2029v9
  30. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 13 to 2
    • Start date changed from estimate of Mar 9, 2024 to Dec 20, 2023
    v8
  31. Study completion date: Jul 10, 2029 to Jul 29, 2029v7
  32. Start date: Jan 23, 2024 to Mar 9, 2024v6
  33. Start date: Jan 8, 2024 to Jan 23, 2024v5
  34. Start date: Nov 13, 2023 to Jan 8, 2024v4
  35. Start date: Dec 29, 2023 to Nov 13, 2023v2
  36. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (39)

Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Time to First Occurrence of IUT or Hydrops Fetalis
Neonatal Mortality and Morbidity Index (NMMI) in Liveborn Neonates
Number of IUT's Received During the Pregnancy
Percentage of Pregnancies With Fetal Loss
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Percentage of Pregnancies With Fetal or Neonatal Death
Percentage of Pregnancies With Hydrops Fetalis
Percentage of Pregnancies Receiving IUT During Pregnancy
Gestational Age (GA) at First IUT
Percentage of Pregnancies Receiving >1 IUT During Pregnancy
Percentage of Pregnancies Receiving IUT or HDFN Resulting in Fetal Demise (Less Than) <GA Week 20
Gestational Age at Delivery
Percentage of Pregnancies With Neonatal Death Through the Neonatal Period
Percentage of Liveborn Neonates With HDFN-related Morbidities Other Than Anemia and Hyperbilirubinemia or Jaundice
Absolute Weight of Liveborn Neonates or Infants
Change From Baseline in Weight of Liveborn Neonates or Infants
Liveborn Neonates Length of Stay in Neonatal Intensive Care Unit
Percentage of Liveborn Neonates Receiving Exchange Transfusions for HDFN
Number of Neonatal Exchange Transfusions per Liveborn Neonate
Percentage of Liveborn Neonates or Infants with Simple Transfusions for HDFN
Number of Simple Transfusions for HDFN per Liveborn Neonate or Infant
Percentage of Liveborn Neonates With Hyperbilirubinemia Treated With Phototherapy
Number of Days of Phototherapy Received for Hyperbilirubinemia per Liveborn Neonate
Percentage of Liveborn Neonates or Infants Receiving Intravenous Immunoglobulin (IVIg) for HDFN Treatment
Number of Maternal Deaths
Number of Participants with Adverse Events (AEs)
Number of Maternal Pregnancy Complications
Number of IUT Related complications
Percentage of Pregnancies With Cesarean Delivery, Preterm Birth, Fetal Growth, and Preeclampsia
Percentage of Liveborn Neonates or Infants Who Died
Percentage of Liveborn Neonates or Infants With AEs
Percentage of Liveborn Neonates or Infants Receiving IVIg for Non-HDFN Indications
Percentage of Liveborn Neonates or Infants With Abnormal Hearing
Bayley Scales of Infant Development and Toddler Development
Change From Baseline in Generalized Anxiety Disorder 7-Item (GAD7) Over time During Pregnancy and Postpartum
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Score
Change From Baseline in EuroQol Five-dimension Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Change From Baseline in EuroQol 5-Dimension Descriptive (EQ-5D) Index Score
Infant Health-Related Quality of Life Instrument (IQI) Score for Neonate or Infant Overtime

Arms and interventions

NipocalimabExperimental

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

PlaceboPlacebo comparator

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

Drugs: Nipocalimab, Placebo

Sites

69 sites in 18 countries

United States 22, United Kingdom 6, Brazil 5, Japan 5, Canada 4, France 3, Germany 3, Israel 3, Poland 3, Spain 3, Argentina 2, Australia 2, Austria 2, Belgium 2, Ireland 1, Italy 1, Netherlands 1, Sweden 1