Back to Trials
NCT05912517PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

12/20/2023

Completion Date

10/8/2029

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 Criteria

Age Range: 18 years to 45 years

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.

Interventions

DRUG

Nipocalimab

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Hemolytic Disease of the Fetus and Newborn

Locations

University of California at San Diego

La Jolla, California 92037

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California 90027

United States

UC Davis School of Medicine

Sacramento, California 95817

United States

Childrens Hospital Colorado

Aurora, Colorado 80045

United States

University of Miami

Miami, Florida 33136

United States

Advocate Children's Hospital

Park Ridge, Illinois 60068

United States

Riley Children s Hospital

Indianapolis, Indiana 46202

United States

University of Kentucky Medical Center

Lexington, Kentucky 40536

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Boston Childrens Hospital

Boston, Massachusetts 02115

United States

Midwest Fetal Care Center

Minneapolis, Minnesota 55404

United States

Columbia University Medical Center

New York, New York 10032

United States

University of North Carolina (UNC) - School of Medicine

Chapel Hill, North Carolina 27599-7516

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Lehigh Valley Hospital

Allentown, Pennsylvania 18103-6218

United States

University of Texas Dell Medical School Department of Women's Health

Austin, Texas 78723

United States

University Of Texas Medical Branch At Galveston

Galveston, Texas 77555

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Norfolk, Virginia 23507

United States

Hospital Italiano de Buenos Aires

Buenos Aires, C1199

Argentina

Hospital Privado Universitario De Cordoba

Córdoba, X5016KEH

Argentina

Mater Hospital Brisbane

South Brisbane, 4101

Australia

Liverpool Hospital

Sydney, 2170

Australia

Medizinische Universitaet Graz

Graz, 8036

Austria

Medizinische Universitaet Wien

Vienna, 1090

Austria

C.H.U. Brugmann

Brussels, 1020

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Universidade Federal De Minas Gerais

Belo Horizonte, 30130100

Brazil

Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG

Goiânia, 74605-050

Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, 50070902

Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, 22281 100

Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403-010

Brazil

BC Women's Hospital University of British Columbia

Vancouver, British Columbia V6H 3N1

Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5

Canada

Centre Hospitalier Sainte Justine

Montreal, Quebec H3T 1C5

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant

Bron, 69500

France

CHRU Lille

Lille, 59000

France

Hopital Armand Trousseau

Paris, 75012

France

Charite Universitaetsmedizin Berlin

Berlin, 10117

Germany

Universitaetsklinikum Giessen und Marburg Standort Giessen

Giessen, 35392

Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20251

Germany

Rotunda Hospital

Dublin, D01 P5W9

Ireland

Hadassah mount scopus

Jerusalem, 91240

Israel

Rabin Medical Center

Petah Tikva, 49100

Israel

The Chaim Sheba Medical Center

Ramat Gan, 5265601

Israel

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Kyushu University Hospital

Fukuoka, 812 8582

Japan

Gifu Prefectural General Medical Center

Gifu, 500-8717

Japan

Osaka Womens and Childrens Hospital

Izumi-shi, 594-1101

Japan

Toho University Medical Center Omori Hospital

Ōta-ku, 143-8541

Japan

Miyagi Childrens Hospital

Sendai, 989-3126

Japan

Leiden University Medical Center

Leiden, 2333 ZA

Netherlands

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. Univ. La Paz

Madrid, 28046

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Karolinska Universitetssjukhuset Huddinge

Stockholm, 14186

Sweden

Birmingham Women's Hospital

Birmingham, B15 2TG

United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF

United Kingdom

Kings College Hospital

London, SE5 9RS

United Kingdom

St Georges Hospital

London, SW17 0QT

United Kingdom

St.Mary's Hospital

Manchester, M13 9WL

United Kingdom

John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom