A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Recruiting Phase 3 Interventional Study
Hemolytic Disease of the Fetus and Newborn
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13\^0/7 to Week 18\^6/7 at randomization * History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as documented: 1. fetal anemia as result of HDFN…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT