RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT05912517

Registry updated: 2026-09-25

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Description

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.

Interventions

Nipocalimab (Drug)
Nipocalimab will be administered as an intravenous infusion.
Placebo (Drug)
Placebo will be administered as an intravenous infusion.

Eligibility criteria

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.

Conditions

Hemolytic Disease of the Fetus and Newborn

Locations

University of California at San Diego — La Jolla, California, United States
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
University of Miami — Miami, Florida, United States
Advocate Children's Hospital — Park Ridge, Illinois, United States
Riley Children s Hospital — Indianapolis, Indiana, United States
University of Iowa — Iowa City, Iowa, United States
University of Kentucky Medical Center — Lexington, Kentucky, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Boston Childrens Hospital — Boston, Massachusetts, 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
Intermountain Medical Center — Murray, Utah, United States
Macon & Joan Brock Virginia Health Sciences at Old Dominion University — 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 Graz — Graz, Austria
Medizinische Universitaet Wien — Vienna, Austria
C.H.U. Brugmann — Brussels, Belgium
Universitair Ziekenhuis Leuven — Leuven, Belgium
Faculdade de Medicina Universidade Federal de Minas Gerais — Belo Horizonte, Brazil
Hospital das Clinicas - UFG — Goiânia, Brazil
Instituto de Medicina Integral Professor Fernando Figueira — Recife, Brazil
IDOR - Regional Rio de Janeiro — 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
Mount Sinai Hospital — Toronto, Ontario, 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
Universitaetsklinikum Hamburg Eppendorf — Hamburg, 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 — Roma, Italy
Kyushu University Hospital — Fukuoka, Japan
Gifu Prefectural General Medical Center — Gifu, Japan
Osaka Womens and Childrens Hospital — Izumi-shi, Japan
Toho University Medical Center Omori Hospital — Ōta-ku, Japan
Miyagi Childrens 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
Kings College Hospital — London, United Kingdom
St Georges Hospital — London, United Kingdom
St.Mary's Hospital — Manchester, United Kingdom
John Radcliffe Hospital — Oxford, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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