Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Pregnant and an estimated gestational age from week 13 to 18 at visit 1
• 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
Locations
United States
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Other Locations
Austria
Medizinische Universitaet Graz
RECRUITING
Graz
Medical University Vienna
RECRUITING
Vienna
Germany
Universitaetsklinikum Giessen und Marburg GmbH
RECRUITING
Giessen
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitatsklinikum Jena
RECRUITING
Jena
Universitaetsklinikum Tuebingen
RECRUITING
Tübingen
Poland
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
Instytut Matki i Dziecka
RECRUITING
Warsaw
Panstwowy Instytut Medyczny MSWiA w Warszawie
RECRUITING
Warsaw
United Kingdom
Birmingham Women's Hospital
RECRUITING
Birmingham
Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital
RECRUITING
Liverpool
Queen Charlotte's and Chelsea Hospital
RECRUITING
London
John Radcliffe Hospital
RECRUITING
Oxford
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2025-02-10
Estimated Completion Date:2029-12-05
Participants
Target number of participants:50
Treatments
Experimental: 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.
Experimental: 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.