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Recruiting Phase 3

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

NCT06449651 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2024-11-11
Last updated
2026-09-25

Condition(s) studied

Thrombocytopenia, Neonatal Alloimmune

Investigational drug(s) / intervention(s)

Nipocalimab →Placebo

Nipocalimab: Nipocalimab will be administered intravenously.

Placebo: Placebo will be administered intravenously.

Study summary

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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization * 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 a clinical review of the 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: * Currently pregnant with multiple gestations (twins or more) * 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

Primary outcome measure(s)

  • Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L — Up to 1 week post birth
    Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.

Trial sites (21)

FacilityCityRegionStatus
Universitair Ziekenhuis Leuven Leuven Belgium Recruiting
Instituto de Medicina Integral Professor Fernando Figueira Recife Brazil Completed
IDOR - Regional Rio de Janeiro Rio de Janeiro Brazil Completed
Hospital Das Clinicas Da Faculdade De Medicina Da USP São Paulo Brazil Completed
CHRU Lille Lille France Recruiting
Hopital trousseau- APHP Paris France Recruiting
Semmelweis Egyetem Budapest Hungary Recruiting
Sheba Medical Center Ramat Gan Israel Completed
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico Milan Italy Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS Rome Italy Recruiting
Haukeland University Hospital Bergen Norway Recruiting
Oslo University Hospital HF Ulleval sykehus Oslo Norway Recruiting
Universitetssykehuset Nord-Norge HF Tromsø Norway Recruiting
St. Olavs Hospital Trondheim Norway Recruiting
Univerzitna nemocnica L. Pasteura Kosice Košice Slovakia Recruiting
Univerzitná nemocnica Martin Martin Slovakia Recruiting
Fakultna nemocnica s poliklinikou Nove Zamky Nové Zámky Slovakia Recruiting
Univerzitetni klinicni center Ljubljana Ljubljana Slovenia Recruiting
Hosp. Virgen Del Rocio Seville Spain Completed
Karolinska Universitetssjukhuset Huddinge Stockholm Sweden Recruiting
Centre Hospitalier Universitaire Vaudois CHUV Lausanne Switzerland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06449651 on ClinicalTrials.gov ↗ ← All trials in Italy