A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT ID: NCT06449651
Last Updated: 2025-11-10
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
39 participants
INTERVENTIONAL
2024-11-11
2029-12-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Placebo will be administered intravenously.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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
Review additional registry numbers or institutional identifiers associated with this trial.
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