A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT ID: NCT06533098
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
50 participants
INTERVENTIONAL
2025-02-10
2029-12-05
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 2: Intravenous Immunoglobins (IVIG)
Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive IVIG from GA week 12 for high-risk pregnancies or GA week 20 for standard-risk pregnancies. Additionally, prednisone will be added per study protocol. Participants will be gradually tapered off prednisone after delivery as per investigator judgement or maternal participant tolerance.
Intravenous immunoglobulins (IVIG)
IVIG will be administered intravenously.
Prednisone
Prednisone will be administered orally.
Arm 1: Nipocalimab
Maternal participants with alloantibodies against HPA-1a and/or HPA-5b will be randomized to receive nipocalimab starting at gestational age (GA) week 13 to 18 until before delivery.
Nipocalimab
Nipocalimab 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.
Intravenous immunoglobulins (IVIG)
IVIG will be administered intravenously.
Prednisone
Prednisone will be administered orally.
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 FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\*10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
* Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal 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, to IVIG or to prednisone
* 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.
UC Davis School of Medicine
Sacramento, California, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medizinische Universitaet Graz
Graz, , Austria
Medical University Vienna
Vienna, , Austria
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsklinikum Jena
Jena, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Leiden University Medical Center
Leiden, , Netherlands
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Instytut Matki i Dziecka
Warsaw, , Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie
Warsaw, , Poland
Birmingham Women's Hospital
Birmingham, , United Kingdom
Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
Liverpool, , United Kingdom
Queen Charlotte's and Chelsea Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
80202135FNAIT3003
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509434-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
80202135FNAIT3003
Identifier Type: -
Identifier Source: org_study_id