A Phase 3 Study of Nipocalimab in Pregnancies at Risk for Sever HDFN (AZALEA Study)

Full Clinical Trial Name

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)

Clinical Trial

  • Obstetrics and Gynecology

Phase

Phase
3

Patient Type

Adult
Doctor(s) running this study
Meredith L. Rochon, MD
Location(s):
Call 610-402-9543
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Purpose

The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo (non-active medication) 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 (HDFN). 

Description

(HDFN) is a rare and potentially life-threatening maternal-fetal disease that can lead to serious health complications for the baby. HDFN occurs when there is an incompatibility between the mother’s and baby’s red blood cells. The mother’s immune system responds to the incompatibility by producing antibodies that seek out the baby’s red blood cells and tries to get rid of them.

Participation in this clinical trial includes weekly intravenous (IV) infusions while visiting the trial site approximately 20 - 23 times during your pregnancy. You will be randomly assigned to receive an infusion of the investigational medication; this can be the active investigational medication or placebo. After your child’s birth, you will have three additional trial site visits over the course of six months, and your child will have six trial site visits over the course of two years.
 

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

  • Female, 18 to 45 years of age, inclusive, at the time of informed consent
  • History of severe HDFN in a prior pregnancy
  • Agrees to receive recommended vaccinations according to local standard of care for both maternal participant and infant throughout the course of the study.
  • Presence of maternal alloantibody to RhD, Kell, Rhc, RhE, or RhC antigen with titers above the critical level
  • Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cffDNA

To Participate

Please contact the Network Office of Research and Innovation at 610-402-9543.

Learn more about the full clinical trial

Full description at clinicaltrials.gov

Doctor(s) running this study