NCT05912517From ClinicalTrials.govRecruiting

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

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)

Hemolytic Disease of the Fetus and Newborn

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 120
Started: 20 December 2023
Main results due: 5 August 2027
Study sites: 65
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 45 years.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(65)

University of California at San Diego
La Jolla, California, United States
Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Recruiting
UC Davis School of Medicine
Sacramento, California, United States
Recruiting
Childrens Hospital Colorado
Aurora, Colorado, United States
Recruiting
University of Miami
Miami, Florida, United States
Recruiting
Advocate Children's Hospital
Park Ridge, Illinois, United States
Recruiting
Riley Children s Hospital
Indianapolis, Indiana, United States
Suspended
University of Iowa
Iowa City, Iowa, United States
Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, United States
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States
Recruiting
Boston Childrens Hospital
Boston, Massachusetts, United States
Recruiting
Midwest Fetal Care Center
Minneapolis, Minnesota, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
University of North Carolina (UNC) - School of Medicine
Chapel Hill, North Carolina, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Oregon Health and Science University
Portland, Oregon, United States
Recruiting
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Recruiting
University of Texas Dell Medical School Department of Women's Health
Austin, Texas, United States
Recruiting
University Of Texas Medical Branch At Galveston
Galveston, Texas, United States
Recruiting
Intermountain Medical Center
Murray, Utah, United States
Recruiting
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, United States
Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Recruiting
Hospital Privado Universitario De Cordoba
Córdoba, Argentina
Recruiting
Mater Hospital Brisbane
South Brisbane, Australia
Recruiting
Liverpool Hospital
Sydney, Australia
Recruiting
Medizinische Universitaet Graz
Graz, Austria
Recruiting
Medizinische Universitaet Wien
Vienna, Austria
Recruiting
C.H.U. Brugmann
Brussels, Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
Faculdade de Medicina Universidade Federal de Minas Gerais
Belo Horizonte, Brazil
Recruiting
Hospital das Clinicas - UFG
Goiânia, Brazil
Recruiting
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil
Recruiting
IDOR - Regional Rio de Janeiro
Rio de Janeiro, Brazil
Recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
Recruiting
BC Women's Hospital University of British Columbia
Vancouver, British Columbia, Canada
Recruiting
Mount Sinai Hospital
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier Sainte Justine
Montreal, Quebec, Canada
Recruiting
McGill University Health Centre
Montreal, Quebec, Canada
Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, France
Recruiting
CHRU Lille
Lille, France
Recruiting
Hopital Armand Trousseau
Paris, France
Recruiting
Charite Universitaetsmedizin Berlin
Berlin, Germany
Recruiting
Universitaetsklinikum Giessen und Marburg Standort Giessen
Giessen, Germany
Recruiting
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
Recruiting
Rotunda Hospital
Dublin, Ireland
Recruiting
Hadassah mount scopus
Jerusalem, Israel
Recruiting
Rabin Medical Center
Petah Tikva, Israel
Recruiting
The Chaim Sheba Medical Center
Ramat Gan, Israel
Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
Recruiting
Kyushu University Hospital
Fukuoka, Japan
Completed
Gifu Prefectural General Medical Center
Gifu, Japan
Recruiting
Osaka Womens and Childrens Hospital
Izumi-shi, Japan
Recruiting
Toho University Medical Center Omori Hospital
Ōta-ku, Japan
Recruiting
Miyagi Childrens Hospital
Sendai, Japan
Completed
Leiden University Medical Center
Leiden, Netherlands
Recruiting
Hosp Univ Vall D Hebron
Barcelona, Spain
Recruiting
Hosp. Univ. La Paz
Madrid, Spain
Recruiting
Hosp. Virgen Del Rocio
Seville, Spain
Recruiting
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Recruiting
Birmingham Women's Hospital
Birmingham, United Kingdom
Recruiting

Showing 60 of 65 sites — filter to narrow it down. 61 of the 65 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05912517. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me