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

PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 20, 2023

Primary Completion Date

August 5, 2027

Study Completion Date

July 10, 2029

Conditions
Hemolytic Disease of the Fetus and Newborn
Interventions
DRUG

Nipocalimab

Nipocalimab will be administered as an intravenous infusion.

DRUG

Placebo

Placebo will be administered as an intravenous infusion.

Trial Locations (56)

1020

RECRUITING

C.H.U. Brugmann, Brussels

1090

RECRUITING

Medizinische Universitaet Wien, Vienna

2170

RECRUITING

Liverpool Hospital, Sydney

3000

RECRUITING

Universitair Ziekenhuis Leuven, Leuven

4101

RECRUITING

Mater Hospital Brisbane, South Brisbane

10032

RECRUITING

Columbia University Medical Center, New York

10117

RECRUITING

Charite Universitaetsmedizin Berlin, Berlin

14186

RECRUITING

Karolinska Universitetssjukhuset Huddinge, Stockholm

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

23507

RECRUITING

Eastern Virginia Medical School, Norfolk

28046

RECRUITING

Hosp. Univ. La Paz, Madrid

35392

RECRUITING

Universitaetsklinikum Giessen und Marburg Standort Giessen, Giessen

40536

RECRUITING

University of Kentucky Medical Center, Lexington

41013

RECRUITING

Hosp. Virgen Del Rocio, Seville

45267

RECRUITING

University of Cincinnati, Cincinnati

46202

RECRUITING

Riley Children s Hospital, Indianapolis

49100

RECRUITING

Rabin Medical Center, Petah Tikva

55404

RECRUITING

Midwest Fetal Care Center, Minneapolis

59000

RECRUITING

CHRU Lille, Lille

60068

RECRUITING

Advocate Children's Hospital, Park Ridge

69500

RECRUITING

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

75012

RECRUITING

Hopital Armand Trousseau, Paris

77555

RECRUITING

University Of Texas Medical Branch At Galveston, Galveston

78723

RECRUITING

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

80045

RECRUITING

Childrens Hospital Colorado, Aurora

90027

RECRUITING

Kaiser Permanente Los Angeles Medical Center, Los Angeles

91240

RECRUITING

Hadassah mount scopus, Jerusalem

95817

RECRUITING

UC Davis School of Medicine, Sacramento

97239

RECRUITING

Oregon Health and Science University, Portland

5265601

RECRUITING

The Chaim Sheba Medical Center, Ramat Gan

30130100

RECRUITING

Universidade Federal De Minas Gerais, Belo Horizonte

50070902

RECRUITING

Instituto de Medicina Integral Professor Fernando Figueira, Recife

27599-7516

RECRUITING

University of North Carolina (UNC) - School of Medicine, Chapel Hill

18103-6218

RECRUITING

Lehigh Valley Hospital, Allentown

C1199

RECRUITING

Hospital Italiano de Buenos Aires, Buenos Aires

X5016KEH

RECRUITING

Hospital Privado Universitario De Cordoba, Córdoba

74605-050

RECRUITING

Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG, Goiânia

22281 100

RECRUITING

Instituto D Or de Pesquisa e Ensino IDOR, Rio de Janeiro

05403-010

RECRUITING

Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo

V6H 3N1

RECRUITING

BC Women's Hospital University of British Columbia, Vancouver

H3T 1C5

RECRUITING

Centre Hospitalier Sainte Justine, Montreal

H4A 3J1

RECRUITING

McGill University Health Centre, Montreal

D01 P5W9

RECRUITING

Rotunda Hospital, Dublin

00168

RECRUITING

Fondazione Policlinico Universitario A Gemelli IRCCS, Rome

812 8582

RECRUITING

Kyushu University Hospital, Fukuoka

500-8717

RECRUITING

Gifu Prefectural General Medical Center, Gifu

594-1101

RECRUITING

Osaka Women's and Children's Hospital, Izumi-shi

143-8541

RECRUITING

Toho University Medical Center Omori Hospital, Ōta-ku

989-3126

COMPLETED

Miyagi Children's Hospital, Sendai

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

08035

RECRUITING

Hosp Univ Vall D Hebron, Barcelona

B15 2TG

RECRUITING

Birmingham Women's Hospital, Birmingham

LS9 7TF

RECRUITING

Leeds Teaching Hospitals NHS Trust, Leeds

SW17 0QT

RECRUITING

St Georges Hospital, London

M13 9WL

RECRUITING

St.Mary's Hospital, Manchester

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY