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A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

RecruitingPhase 3

Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Who can join

Ages 18 to 45 · Women

Full eligibility criteria
Inclusion Criteria:

* Pregnant and an estimated gestational age (GA) from week 13\* to 18 at visit 1

  \*Randomization for high-risk FNAIT participants to occur at GA Week 12
* 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:

* 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, 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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 50 · Started: Feb 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06533098

Locations in the U.S.

AlabamaThe University of Alabama at Birmingham, Birmingham
CaliforniaUC Davis School of Medicine, Sacramento
ColoradoChildrens Hospital Colorado, Aurora
IllinoisAdvocate Children's Hospital, Park Ridge
IowaUniversity of Iowa Hospital and Clinics, Iowa City
New YorkUniversity of Rochester Medical Center, Rochester
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
OhioUniversity of Cincinnati, Cincinnati
OregonOregon Health And Science University, Portland
PennsylvaniaHospital of the University of Pennsylvania, Philadelphia
TexasUniversity of Texas Medical Branch, Galveston
UtahUniversity of Utah, Salt Lake City

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.