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)
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death — 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).
Trial sites (64)
Facility
City
Region
Status
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
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.
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