A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT ID: NCT06449651
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
39 participants
INTERVENTIONAL
2024-11-11
2029-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nipocalimab
Maternal participants will receive nipocalimab Intravenously (IV).
Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Maternal participants will receive placebo IV.
Placebo
Placebo will be administered intravenously.
Interventions
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Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Placebo will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records
* Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
* For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
Exclusion Criteria
* 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 excipients (refer to the Investigator Brochure (IB))
* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
18 Years
45 Years
FEMALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Universitair Ziekenhuis Leuven
Leuven, , Belgium
Instituto de Medicina Integral Professor Fernando Figueira
Recife, , Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
CHRU Lille
Lille, , France
Hopital trousseau- APHP
Paris, , France
Semmelweis Egyetem
Budapest, , Hungary
Sheba Medical Center
Ramat Gan, , Israel
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, , Italy
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital HF Ulleval sykehus
Oslo, , Norway
Universitetssykehuset Nord-Norge HF
Tromsø, , Norway
St. Olavs Hospital
Trondheim, , Norway
Univerzitna nemocnica L. Pasteura Kosice
Košice, , Slovakia
Univerzitná nemocnica Martin
Martin, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, , Slovakia
Univerzitetni klinicni center Ljubljana
Ljubljana, , Slovenia
Hosp. Virgen Del Rocio
Seville, , Spain
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, , Switzerland
Countries
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Central Contacts
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References
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Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2025 Aug 20. doi: 10.1055/a-2666-5642. Online ahead of print.
Other Identifiers
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80202135FNAIT3001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504307-88-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
80202135FNAIT3001
Identifier Type: -
Identifier Source: org_study_id
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