Evaluating nipocalimab and IVIG for preventing fetal and neonatal thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the efficacy and safety of nipocalimab compared to intravenous immunoglobulin (IVIG) in pregnant women at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Participants will be pregnant women between 13 to 18 weeks of gestation who have a history of FNAIT and specific maternal alloantibodies. The study will assess how well nipocalimab can reduce the risk of severe thrombocytopenia in their fetuses and neonates. The approach involves monitoring maternal health and fetal outcomes throughout the pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant and an estimated gestational age (GA) from week 13\* to 18 at visit 1

  \*Randomization for high-risk FNAIT participants to occur at GA Week 12
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with FNAIT based on medical records including: a) neonatal platelet count less than (\<) 150\*10\^9/Liter with no fetal/neonatal intracranial hemorrhage (ICH) or severe fetal/neonatal hemorrhage (standard-risk) OR b) fetus/neonate with ICH or severe hemorrhage in a fetus/neonate (high-risk)
* Current pregnancy with presence of maternal anti-HPA-1a and/or anti-HPA-5b alloantibody and positive fetal HPA-1a and/or HPA-5b genotype as confirmed by cell-free fetal DNA in maternal blood
* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
* For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:

* Currently pregnant with multiple gestations (twins or more)
* History of severe preeclampsia in a previous pregnancy
* History of myocardial infarction, unstable ischemic heart disease, or stroke
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, to IVIG or to prednisone that would preclude treatment
* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Where it's running

• The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• UC Davis School of Medicine
  Sacramento, California, United States Recruiting
• Childrens Hospital Colorado
  Aurora, Colorado, United States Recruiting
• University of Florida at Shands
  Gainesville, Florida, United States Recruiting
• Advocate Children's Hospital
  Park Ridge, Illinois, United States Recruiting
• University of Iowa Hospital and Clinics
  Iowa City, Iowa, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.