A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502629-16-00

Acronym

80202135EBF3001

Enrollment

Registered

2024-01-18

Start date

2024-07-10

Completion date

Unknown

Last updated

2026-01-22

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

Conditions

Hemolytic Disease of the Fetus and Newborn (HDFN)

Brief summary

The proportion of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period (through 4 weeks of age or 41 weeks PMA, whichever is later).

Interventions

DRUGSaline

DRUG0.9% Sodium Chloride Solution for Injection

DRUGJNJ-80202135

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The proportion of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period (through 4 weeks of age or 41 weeks PMA, whichever is later).	—

Countries

Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

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