Health Trials

A Study of Nipocalimab in Reducing the 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 evaluate the effectiveness of nipocalimab compared with placebo 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; 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

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 (refer to the Investigator Brochure (IB))

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nipocalimab

    Drug

    Nipocalimab will be administered intravenously.

  • Placebo

    Drug

    Placebo will be administered intravenously.

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: NipocalimabActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

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

Neonate/Fetus With Adjudicated Bleeding

Neonate/fetus With adjudicated bleeding will be reported.

Time frame
Up to 1 Week post birth
2

Platelet Count at Birth in a Neonate

Platelet count at birth in a neonate will be reported.

Time frame
At birth
3

Neonate/Fetus with Outcome of Death

Fetus/neonate with outcome of death will be reported.

Time frame
Up to 1 Week post birth
4

Platelet Count at Birth <10×10^9/L in a Neonate

Platelet count at birth \<10×10\^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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