A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Thrombocytopenia, Neonatal Alloimmune
In brief
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).
Key facts
- Study ID
- NCT06449651
- Run by
- Janssen Research & Development, LLC
- People needed
- 39
- Starts
- 2024-11-11
- Expected to finish
- 2029-12-05
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Centre Hospitalier Universitaire Vaudois CHUV — Lausanne, Switzerland (enrolling)
- Instituto de Medicina Integral Professor Fernando Figueira — Recife, Brazil (enrolling)
- Instituto D Or de Pesquisa e Ensino IDOR — Rio de Janeiro, Brazil (enrolling)
- Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo, Brazil (enrolling)
- CHRU Lille — Lille, France (enrolling)
- Hopital trousseau- APHP — Paris, France (enrolling)
- Semmelweis Egyetem — Budapest, Hungary (enrolling)
- Sheba Medical Center — Ramat Gan, Israel (enrolling)
- Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
- Fondazione Policlinico Universitario A Gemelli IRCCS — Rome, Italy (enrolling)
- Haukeland University Hospital — Bergen, Norway (enrolling)
- Oslo University Hospital HF Ulleval sykehus — Oslo, Norway (enrolling)
- Universitetssykehuset Nord-Norge HF — Tromsø, Norway (enrolling)
- St. Olavs Hospital — Trondheim, Norway (enrolling)
- Univerzitna nemocnica L. Pasteura Kosice — Košice, Slovakia (enrolling)
- Univerzitná nemocnica Martin — Martin, Slovakia (enrolling)
- Fakultna nemocnica s poliklinikou Nove Zamky — Nové Zámky, Slovakia (enrolling)
- Univerzitetni klinicni center Ljubljana — Ljubljana, Slovenia (enrolling)
- Universitair Ziekenhuis Leuven — Leuven, Belgium (enrolling)
- Karolinska Universitetssjukhuset Huddinge — Stockholm, Sweden (enrolling)
- Hosp. Virgen Del Rocio — Seville, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.