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Clinical Trial Summary

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby is developing in the womb) with live neonates in pregnant participants at risk for severe hemolytic disease of the fetus and newborn.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Hemolysis
  • Hemolytic Disease of the Fetus and Newborn

NCT number NCT05912517
Study type Interventional
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Status Recruiting
Phase Phase 3
Start date December 20, 2023
Completion date July 10, 2029

See also
  Status Clinical Trial Phase
Active, not recruiting 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) Phase 2