Actively Recruiting
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
120
Participants Needed
61
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with estimated gestational age from 13 weeks 0 days to 18 weeks 6 days at randomization
- History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy with documented fetal anemia, hydrops, intrauterine transfusion, fetal loss, or neonatal death due to HDFN
- Maternal alloantibody titers above critical levels (anti-Kell 74; 4; others 74; 16) with evidence of an antigen-positive fetus
- Presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above critical levels in current pregnancy
- Evidence of antigen positivity for current maternal alloantibody confirmed by non-invasive cell-free fetal DNA testing
- Screening lab tests within protocol-specified ranges for albumin, liver enzymes, creatinine, and immunoglobulin G
- Medically stable based on physical exam, medical history, vital signs, ECG, and clinical labs
You will not qualify if you...
- Currently pregnant with multiple gestation (twins or more)
- Evidence of fetal anemia before randomization in current pregnancy
- History of severe preeclampsia before 34 weeks gestation or severe fetal growth restriction in previous pregnancy
- Current uncontrolled hypertension
- History of myocardial infarction, unstable ischemic heart disease, or stroke
- Confirmed or suspected immunodeficiency or family history of congenital or hereditary immunodeficiency unless ruled out
- Inflammatory or autoimmune diseases needing immunosuppressive therapy that may risk safety
- Current or recent malignancy within 3 years except certain treated skin or cervical cancers with no recurrence
- Current use of systemic corticosteroids or immunosuppressants for non-pregnancy disorders
- Received or planning plasmapheresis, immunoadsorption, intravenous immunoglobulin, or IgG Fc-related therapeutics during this pregnancy
- Severe infections including opportunistic infections
- Abnormal hematologic lab values during screening
- History of unprovoked pulmonary embolism or recurrent deep vein thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 61 locations
1
University of California at San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Actively Recruiting
3
UC Davis School of Medicine
Sacramento, California, United States, 95817
Actively Recruiting
4
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Advocate Children's Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
7
Riley Children s Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
9
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Midwest Fetal Care Center
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
11
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
University of North Carolina (UNC) - School of Medicine
Chapel Hill, North Carolina, United States, 27599-7516
Actively Recruiting
13
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
14
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
15
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103-6218
Actively Recruiting
16
University of Texas Dell Medical School Department of Women's Health
Austin, Texas, United States, 78723
Actively Recruiting
17
University Of Texas Medical Branch At Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
18
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, United States, 23507
Actively Recruiting
19
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199
Actively Recruiting
20
Hospital Privado Universitario De Cordoba
Córdoba, Argentina, X5016KEH
Actively Recruiting
21
Mater Hospital Brisbane
South Brisbane, Australia, 4101
Actively Recruiting
22
Liverpool Hospital
Sydney, Australia, 2170
Actively Recruiting
23
Medizinische Universitaet Graz
Graz, Austria, 8036
Actively Recruiting
24
Medizinische Universitaet Wien
Vienna, Austria, 1090
Actively Recruiting
25
C.H.U. Brugmann
Brussels, Belgium, 1020
Actively Recruiting
26
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
27
Universidade Federal De Minas Gerais
Belo Horizonte, Brazil, 30130100
Actively Recruiting
28
Empresa Brasileira de Servicos Hospitalares EBSERH Hospital das Clinicas da UFG
Goiânia, Brazil, 74605-050
Actively Recruiting
29
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil, 50070902
Actively Recruiting
30
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, Brazil, 22281 100
Actively Recruiting
31
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil, 05403-010
Actively Recruiting
32
BC Women's Hospital University of British Columbia
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
33
Centre Hospitalier Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
34
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
35
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, France, 69500
Actively Recruiting
36
CHRU Lille
Lille, France, 59000
Actively Recruiting
37
Hopital Armand Trousseau
Paris, France, 75012
Actively Recruiting
38
Charite Universitaetsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
39
Universitaetsklinikum Giessen und Marburg Standort Giessen
Giessen, Germany, 35392
Actively Recruiting
40
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
41
Rotunda Hospital
Dublin, Ireland, D01 P5W9
Actively Recruiting
42
Hadassah mount scopus
Jerusalem, Israel, 91240
Actively Recruiting
43
Rabin Medical Center
Petah Tikva, Israel, 49100
Actively Recruiting
44
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
45
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
46
Kyushu University Hospital
Fukuoka, Japan, 812 8582
Actively Recruiting
47
Gifu Prefectural General Medical Center
Gifu, Japan, 500-8717
Actively Recruiting
48
Osaka Women's and Children's Hospital
Izumi-shi, Japan, 594-1101
Actively Recruiting
49
Toho University Medical Center Omori Hospital
Ōta-ku, Japan, 143-8541
Actively Recruiting
50
Miyagi Children's Hospital
Sendai, Japan, 989-3126
Completed
51
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
52
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
53
Hosp. Univ. La Paz
Madrid, Spain, 28046
Actively Recruiting
54
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
55
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 14186
Actively Recruiting
56
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Actively Recruiting
57
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
58
Kings College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
59
St Georges Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
60
St.Mary's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
61
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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