NCT03842189

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.

Conditions

• Hemolytic Disease of the Fetus and Newborn

Interventions

Type	Name	Description
DRUG	M281	Participants will receive once weekly intravenous (IV) infusions of M281

Timeline

• Start date: 2018-04-05
• Primary completion: 2024-08-05
• Completion: 2024-08-05
• First posted: 2019-02-15
• Last updated: 2026-03-25
• Results posted: 2026-01-28

Locations

19 sites across 9 countries: United States, Australia, Belgium, Canada, Germany, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study