Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504307-88-00

Acronym

80202135FNAIT3001

Enrollment

Registered

2024-01-23

Start date

2024-02-20

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Brief summary

Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10⁹/l in a fetus/neonate.

Detailed description

Platelet count at birth in a neonate, Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate

Interventions

DRUGJNJ-80202135

DRUGSaline

DRUG0.9% Sodium Chloride Solution for Injection

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10⁹/l in a fetus/neonate.	—

Secondary

Measure	Time frame
Platelet count at birth in a neonate, Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate	—

Countries

Belgium, France, Germany, Hungary, Italy, Netherlands, Norway, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026