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

Purpose

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).

Condition

  • Thrombocytopenia, Neonatal Alloimmune

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Nipocalimab
    Nipocalimab will be administered intravenously.
    Other names:
    • JNJ-80202135
    • JNJ-86507083
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.
  • Drug: Intravenous immunoglobulins (IVIG)
    IVIG will be administered intravenously.
  • Drug: Prednisone
    Prednisone will be administered orally.

Recruiting Locations

UC Davis School of Medicine
Sacramento 5389489, California 5332921 95817

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599

Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

University of Texas Medical Branch
Galveston 4692883, Texas 4736286 77555

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com