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Clinical Trials in Ireland / NCT05912517
Recruiting Phase 3

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

NCT05912517 · tracked via the Priya Life Science Ireland tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2023-12-20
Last updated
2026-08-28

Condition(s) studied

Hemolytic Disease of the Fetus and Newborn

Investigational drug(s) / intervention(s)

Nipocalimab →Placebo

Nipocalimab: Nipocalimab will be administered as an intravenous infusion.

Placebo: Placebo will be administered as an intravenous infusion.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
University of California at San Diego La Jolla California Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
UC Davis School of Medicine Sacramento California Recruiting
Childrens Hospital Colorado Aurora Colorado Recruiting
University of Miami Miami Florida Recruiting
Advocate Children's Hospital Park Ridge Illinois Recruiting
Riley Children s Hospital Indianapolis Indiana Suspended
University of Kentucky Medical Center Lexington Kentucky Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Boston Childrens Hospital Boston Massachusetts Recruiting
Midwest Fetal Care Center Minneapolis Minnesota Recruiting
Columbia University Medical Center New York New York Recruiting
University of North Carolina (UNC) - School of Medicine Chapel Hill North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Oregon Health and Science University Portland Oregon Recruiting
Lehigh Valley Hospital Allentown Pennsylvania Recruiting
University of Texas Dell Medical School Department of Women's Health Austin Texas Recruiting
University Of Texas Medical Branch At Galveston Galveston Texas Recruiting
Intermountain Medical Center Murray Utah Recruiting
Macon & Joan Brock Virginia Health Sciences at Old Dominion University Norfolk Virginia Recruiting
Hospital Italiano de Buenos Aires Buenos Aires Argentina Recruiting
Hospital Privado Universitario De Cordoba Córdoba Argentina Recruiting
Mater Hospital Brisbane South Brisbane Australia Recruiting
Liverpool Hospital Sydney Australia Recruiting
Medizinische Universitaet Graz Graz Austria Recruiting
Medizinische Universitaet Wien Vienna Austria Recruiting
C.H.U. Brugmann Brussels Belgium Recruiting
Universitair Ziekenhuis Leuven Leuven Belgium Recruiting
Faculdade de Medicina Universidade Federal de Minas Gerais Belo Horizonte Brazil Recruiting
Hospital das Clinicas - UFG Goiânia Brazil Recruiting
Instituto de Medicina Integral Professor Fernando Figueira Recife Brazil Recruiting
IDOR - Regional Rio de Janeiro Rio de Janeiro Brazil Recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP São Paulo Brazil Recruiting
BC Women's Hospital University of British Columbia Vancouver British Columbia Recruiting
Mount Sinai Hospital Toronto Ontario Recruiting
Centre Hospitalier Sainte Justine Montreal Quebec Recruiting
McGill University Health Centre Montreal Quebec Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant Bron France Recruiting
CHRU Lille Lille France Recruiting
Hopital Armand Trousseau Paris France Recruiting

+ 24 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in Ireland

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05912517 on ClinicalTrials.gov ↗ ← All trials in Ireland