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

ClinicalTrials.gov ID: NCT05912517

Public ClinicalTrials.gov record NCT05912517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 19, 2026, 6:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Study identification

NCT ID: NCT05912517
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Hemolytic Disease of the Fetus and Newborn

Interventions

Nipocalimab Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 19, 2023
Primary completion: Aug 4, 2027
Completion: Oct 7, 2029
Last update posted: May 7, 2026

2023 – 2029

United States locations

U.S. sites: 18
U.S. states: 15
U.S. cities: 18

Facility	City	State	ZIP	Site status
University of California at San Diego	La Jolla	California	92037	Recruiting
Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	90027	Recruiting
UC Davis School of Medicine	Sacramento	California	95817	Recruiting
Childrens Hospital Colorado	Aurora	Colorado	80045	Recruiting
University of Miami	Miami	Florida	33136	Recruiting
Advocate Children's Hospital	Park Ridge	Illinois	60068	Recruiting
Riley Children s Hospital	Indianapolis	Indiana	46202	Recruiting
University of Kentucky Medical Center	Lexington	Kentucky	40536	Recruiting
Johns Hopkins Hospital	Baltimore	Maryland	21287	Recruiting
Midwest Fetal Care Center	Minneapolis	Minnesota	55404	Recruiting
Columbia University Medical Center	New York	New York	10032	Recruiting
University of North Carolina (UNC) - School of Medicine	Chapel Hill	North Carolina	27599-7516	Recruiting
University of Cincinnati	Cincinnati	Ohio	45267	Recruiting
Oregon Health and Science University	Portland	Oregon	97239	Recruiting
Lehigh Valley Hospital	Allentown	Pennsylvania	18103-6218	Recruiting
University of Texas Dell Medical School Department of Women's Health	Austin	Texas	78723	Recruiting
University Of Texas Medical Branch At Galveston	Galveston	Texas	77555	Recruiting
Macon & Joan Brock Virginia Health Sciences at Old Dominion University	Norfolk	Virginia	23507	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05912517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 7, 2026 · Synced May 19, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05912517 live on ClinicalTrials.gov.

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