Health Trials

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

ConditionThrombocytopenia, Neonatal Alloimmune
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorJanssen Research & Development, LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant and an estimated gestational age (GA) 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nipocalimab

    Drug

    Nipocalimab will be administered intravenously.

  • Intravenous immunoglobulins (IVIG)

    Drug

    IVIG will be administered intravenously.

  • Prednisone

    Drug

    Prednisone will be administered orally.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm 1: NipocalimabExperimental treatment 1 intervention
Group B: Arm 2: Intravenous Immunoglobins (IVIG)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L

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.

Time frame
Up to 1 Week post birth

Secondary outcomes

1

Platelet Count at Birth in a Neonate

Platelet count at birth in a neonate will be reported.

Time frame
At birth
2

Neonate/Fetus with Outcome of Death

Fetus/neonate with outcome of death will be reported.

Time frame
Up to 1 Week post birth
3

Neonate with Platelet Count at Birth <10*10^9/L

Platelet count at birth \<10\*10\^9/L in a neonate will be reported.

Time frame
At birth
4

Neonate with Platelet Count at Birth <30*10^9/L

Platelet count at birth \<30\*10\^9/L in a neonate will be reported.

Time frame
At birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
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