Actively Recruiting
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
39
Participants Needed
21
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
CONDITIONS
Official Title
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with estimated gestational age between 13 and 18 weeks at randomization
- History of at least one prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) without severe bleeding or intracranial hemorrhage
- Current pregnancy with maternal anti-human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype confirmed by cell-free fetal DNA
- Stable health status based on physical exam, medical history, vital signs, ECG, and lab tests at screening
- Willing to avoid participation in another investigational therapy study until last follow-up visit for both mother and baby
You will not qualify if you...
- Currently pregnant with twins or more (multiple gestations)
- History of severe preeclampsia in a previous pregnancy
- History of myocardial infarction, unstable ischemic heart disease, or stroke
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its ingredients
- Confirmed or suspected immunodeficiency syndrome or family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil, 50070-902
Actively Recruiting
3
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, Brazil, 22281 00
Actively Recruiting
4
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil, 05403 000
Actively Recruiting
5
CHRU Lille
Lille, France, 59000
Actively Recruiting
6
Hopital trousseau- APHP
Paris, France, 75012
Actively Recruiting
7
Semmelweis Egyetem
Budapest, Hungary, 1082
Actively Recruiting
8
Sheba Medical Center
Ramat Gan, Israel, 5262000
Actively Recruiting
9
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
10
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
11
Haukeland University Hospital
Bergen, Norway, 5009
Actively Recruiting
12
Oslo University Hospital HF Ulleval sykehus
Oslo, Norway, 0455
Actively Recruiting
13
Universitetssykehuset Nord-Norge HF
Tromsø, Norway, 9019
Actively Recruiting
14
St. Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
15
Univerzitna nemocnica L. Pasteura Kosice
Košice, Slovakia, 04190
Actively Recruiting
16
Univerzitná nemocnica Martin
Martin, Slovakia, 036 01
Actively Recruiting
17
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia, 940 34
Actively Recruiting
18
Univerzitetni klinicni center Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
19
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
20
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, SE-141 86
Actively Recruiting
21
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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