Cell-Free DNA Analysis for the Determination of Fetal Red Blood Cell Antigen Genotype in Individuals With Alloimmunized Pregnancies.
Shannon Rego, Olaide Ashimi Balogun, Kirsten Emanuel...
https://pubmed.ncbi.nlm.nih.gov/39053010Actively Recruiting
Phase 3
Age: 18Years - 45Years
FEMALE
ID05912517
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
120
Participants Needed
62
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating nipocalimab to reduce the risk of fetal anemia in pregnant individuals at risk for severe hemolytic disease of the fetus and newborn (HDFN). This condition involves a decrease in the baby's red blood cell volume during pregnancy. The study is a Phase 3 randomized, placebo-controlled trial aiming to compare nipocalimab's effectiveness to placebo in protecting live neonates from complications related to HDFN. Participants will receive either nipocalimab or a placebo through weekly intravenous infusions starting from randomization until gestational week 35. The study is double-blind and multicenter, ensuring that neither participants nor researchers know which treatment is given. The trial monitors pregnancies from early gestation through delivery and the neonatal period. Participants will be closely followed with assessments during pregnancy and after birth including monitoring for fetal loss, intrauterine transfusions, hydrops fetalis, neonatal death, and other health outcomes up to 104 weeks for the infant. The study also collects data on maternal health, pregnancy complications, infant development, and quality of life. Safety evaluations continue through 24 weeks postpartum, with detailed tracking of treatment effects and infant well-being.
CONDITIONS
Brief Title
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant women 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 in a prior pregnancy with documented fetal anemia, hydrops, intrauterine transfusions, fetal loss, or neonatal death
- Presence of maternal alloantibodies to RhD, Rhc, RhE, RhC, or Kell antigen above critical levels during current pregnancy
- Evidence of antigen-positive fetus confirmed by non-invasive cell-free fetal DNA testing
- Screening lab tests within specified parameters for albumin, liver enzymes, creatinine, and immunoglobulin G
- Medically stable based on physical exam, medical history, vital signs, ECG, and lab tests at screening
You will not qualify if you...
- Currently pregnant with twins or more (multiple gestation)
- 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 high blood pressure
- History of heart attack, unstable heart disease, or stroke
- Confirmed or suspected immunodeficiency or family history of congenital immunodeficiency unless ruled out
- Inflammatory or autoimmune diseases requiring immunosuppressive therapy
- Current or recent malignancy (with specific exceptions for certain treated skin or cervical cancers)
- Current use of systemic corticosteroids or immunosuppressants unrelated to pregnancy
- Received or planning to receive certain immunotherapies during current pregnancy
- Severe infections including opportunistic infections
- Abnormal blood 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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From randomization through gestational age Week 35
Participants receive weekly intravenous infusions of either nipocalimab or placebo from randomization through gestational age Week 35.
Weekly visits for infusions
Follow-up
Duration - Up to 104 weeks postpartum
Participants and their infants are monitored through the neonatal period and up to 104 weeks postpartum for safety and outcomes.
Multiple visits during pregnancy and postpartum for assessments
Trial Site Locations
Total: 62 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
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
34
Centre Hospitalier Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
35
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
36
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, France, 69500
Actively Recruiting
37
CHRU Lille
Lille, France, 59000
Actively Recruiting
38
Hopital Armand Trousseau
Paris, France, 75012
Actively Recruiting
39
Charite Universitaetsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
40
Universitaetsklinikum Giessen und Marburg Standort Giessen
Giessen, Germany, 35392
Actively Recruiting
41
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
42
Rotunda Hospital
Dublin, Ireland, D01 P5W9
Actively Recruiting
43
Hadassah mount scopus
Jerusalem, Israel, 91240
Actively Recruiting
44
Rabin Medical Center
Petah Tikva, Israel, 49100
Actively Recruiting
45
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
46
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
47
Kyushu University Hospital
Fukuoka, Japan, 812 8582
Actively Recruiting
48
Gifu Prefectural General Medical Center
Gifu, Japan, 500-8717
Actively Recruiting
49
Osaka Womens and Childrens Hospital
Izumi-shi, Japan, 594-1101
Actively Recruiting
50
Toho University Medical Center Omori Hospital
Ōta-ku, Japan, 143-8541
Actively Recruiting
51
Miyagi Childrens Hospital
Sendai, Japan, 989-3126
Completed
52
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
53
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
54
Hosp. Univ. La Paz
Madrid, Spain, 28046
Actively Recruiting
55
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
56
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 14186
Actively Recruiting
57
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Actively Recruiting
58
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
59
Kings College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
60
St Georges Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
61
St.Mary's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
62
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
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Research Team
S
Study 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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