A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06449651
Phase
PHASE3
Status
Recruiting
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Conditions

  • Thrombocytopenia, Neonatal Alloimmune

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered intravenously.
  • Placebo — DRUG
    Placebo will be administered intravenously.

Study Details

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).

Key Dates

Start date
Nov 11, 2024
Status verified
Jun 2026
Primary completion
Dec 5, 2029
Completion
Dec 5, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Nipocalimab
    Maternal participants will receive nipocalimab Intravenously (IV).
  • Placebo Comparator: Placebo
    Maternal participants will receive placebo IV.

Primary Outcome Measure

Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L [ Time Frame: Up to 1 week post birth ]

Central Contacts

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