RecruitingPhase 3NCT05912517

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)

Sponsor

Janssen Research & Development, LLC

Enrollment

120 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Hemolytic Disease of the Fetus and Newborn

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nipocalimab and a drug called Placebo for people with hemolytic disease of the fetus and newborn. The study is currently recruiting participants at 61 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNipocalimab

Nipocalimab will be administered as an intravenous infusion.

DRUGPlacebo

Placebo will be administered as an intravenous infusion.

Locations(62)

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 Kentucky Medical Center

Lexington, Kentucky, United States

Johns Hopkins Hospital

Baltimore, Maryland, 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

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

Universidade Federal De Minas Gerais

Belo Horizonte, Brazil

Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG

Goiânia, Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

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

View Full Details on ClinicalTrials.gov

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NCT05912517

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