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

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05912517
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hemolytic Disease of the Fetus and Newborn

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an intravenous infusion.
  • Placebo — DRUG
    Placebo will be administered as an intravenous infusion.

Study Details

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.

Key Dates

Start date
Dec 20, 2023
Status verified
Jun 2026
Primary completion
Aug 5, 2027
Completion
Oct 8, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nipocalimab
    Participants will receive nipocalimab intravenously (IV) once weekly (qw) from randomization through gestational age (GA) Week 35.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo IV qw from randomization through GA Week 35.

Primary Outcome Measure

Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death [ Time Frame: From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of California at San DiegoLa JollaCalifornia92037-
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
UC Davis School of MedicineSacramentoCalifornia95817-
Childrens Hospital ColoradoAuroraColorado80045-
University of MiamiMiamiFlorida33136-
Advocate Children's HospitalPark RidgeIllinois60068-
Riley Children s HospitalIndianapolisIndiana46202-
University of Kentucky Medical CenterLexingtonKentucky40536-
Johns Hopkins HospitalBaltimoreMaryland21287-
Midwest Fetal Care CenterMinneapolisMinnesota55404-
Columbia University Medical CenterNew YorkNew York10032-
University of North Carolina (UNC) - School of MedicineChapel HillNorth Carolina27599-7516-
University of CincinnatiCincinnatiOhio45267-
Oregon Health and Science UniversityPortlandOregon97239-
Lehigh Valley HospitalAllentownPennsylvania18103-6218-
University of Texas Dell Medical School Department of Women's HealthAustinTexas78723-
University Of Texas Medical Branch At GalvestonGalvestonTexas77555-
Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityNorfolkVirginia23507-

Find similar trials in La Jolla, CA

By research site
University of California at San Diego· La Jolla, CAKaiser Permanente Los Angeles Medical Center· Los Angeles, CAUC Davis School of Medicine· Sacramento, CAChildrens Hospital Colorado· Aurora, COUniversity of Miami· Miami, FLAdvocate Children's Hospital· Park Ridge, IL

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