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Study identifier: NCT05912517 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Hemolytic Disease of the Fetus and Newborn  ·  Sponsor: Janssen Research & Development, LLC

PhasePhase 3
Planned participants120
Who can joinFemale, 18 Years to 45 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Study Contact  ·  844-434-4210  ·  Participate-In-This-Study1@its.jnj.com

Always discuss trial participation with your own doctor first.

Locations (62)

University of California at San DiegoLa Jolla, California, United StatesRecruiting
Kaiser Permanente Los Angeles Medical CenterLos Angeles, California, United StatesRecruiting
UC Davis School of MedicineSacramento, California, United StatesRecruiting
Childrens Hospital ColoradoAurora, Colorado, United StatesRecruiting
University of MiamiMiami, Florida, United StatesRecruiting
Advocate Children's HospitalPark Ridge, Illinois, United StatesRecruiting
Riley Children s HospitalIndianapolis, Indiana, United StatesRecruiting
University of Kentucky Medical CenterLexington, Kentucky, United StatesRecruiting
Johns Hopkins HospitalBaltimore, Maryland, United StatesRecruiting
Midwest Fetal Care CenterMinneapolis, Minnesota, United StatesRecruiting
Columbia University Medical CenterNew York, New York, United StatesRecruiting
University of North Carolina (UNC) - School of MedicineChapel Hill, North Carolina, United StatesRecruiting

+ 50 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05912517