A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
NCT ID: NCT05912517
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2023-12-20
2029-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nipocalimab
Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
Nipocalimab
Nipocalimab will be administered as an intravenous infusion.
Placebo
Participants will receive matching placebo IV qw from randomization through GA Week 35.
Placebo
Placebo will be administered as an intravenous infusion.
Interventions
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Nipocalimab
Nipocalimab will be administered as an intravenous infusion.
Placebo
Placebo will be administered as an intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
UC Davis School of Medicine
Sacramento, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Advocate Children's Hospital
Park Ridge, Illinois, United States
Riley Children s Hospital
Indianapolis, Indiana, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Midwest Fetal Care Center
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina (UNC) - School of Medicine
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
University of Texas Dell Medical School Department of Women's Health
Austin, Texas, United States
University Of Texas Medical Branch At Galveston
Galveston, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Privado Universitario De Cordoba
Córdoba, , Argentina
Mater Hospital Brisbane
South Brisbane, , Australia
Liverpool Hospital
Sydney, , Australia
Medizinische Universitaet Wien
Vienna, , Austria
C.H.U. Brugmann
Brussels, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Universidade Federal De Minas Gerais
Belo Horizonte, , Brazil
Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG
Goiânia, , Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, , Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
BC Women's Hospital University of British Columbia
Vancouver, British Columbia, Canada
Centre Hospitalier Sainte Justine
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, , France
CHRU Lille
Lille, , France
Hopital Armand Trousseau
Paris, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Giessen und Marburg Standort Giessen
Giessen, , Germany
Rotunda Hospital
Dublin, , Ireland
Hadassah mount scopus
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, , Italy
Kyushu University Hospital
Fukuoka, , Japan
Gifu Prefectural General Medical Center
Gifu, , Japan
Osaka Women's and Children's Hospital
Izumi-shi, , Japan
Toho University Medical Center Omori Hospital
Ōta-ku, , Japan
Miyagi Children's Hospital
Sendai, , Japan
Leiden University Medical Center
Leiden, , Netherlands
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Birmingham Women's Hospital
Birmingham, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
St Georges Hospital
London, , United Kingdom
St.Mary's Hospital
Manchester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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References
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Rego S, Ashimi Balogun O, Emanuel K, Overcash R, Gonzalez JM, Denomme GA, Hoskovec J, King H, Wilson A, Wynn J, Moise KJ Jr. Cell-Free DNA Analysis for the Determination of Fetal Red Blood Cell Antigen Genotype in Individuals With Alloimmunized Pregnancies. Obstet Gynecol. 2024 Oct 1;144(4):436-443. doi: 10.1097/AOG.0000000000005692. Epub 2024 Jul 25.
Related Links
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Azalea Study Website (for the United States only)
Other Identifiers
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80202135EBF3001
Identifier Type: OTHER
Identifier Source: secondary_id
2021-002359-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502629-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109199
Identifier Type: -
Identifier Source: org_study_id