Evaluating nipocalimab and IVIG for preventing fetal and neonatal thrombocytopenia
Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
This study is testing if a new treatment called nipocalimab can help pregnant women with a history of fetal and neonatal thrombocytopenia keep their babies' platelet levels safe compared to standard treatment with IVIG.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | nipocalimab, prednisone |
| Locations | 24 sites (Birmingham, Alabama and 23 other locations) |
| Trial ID | NCT06533098 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with a history of FNAIT and specific maternal alloantibodies between 13 to 18 weeks of gestation.
Not a fit: Patients who do not have a history of FNAIT or those without the required maternal alloantibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of severe fetal and neonatal thrombocytopenia, improving outcomes for affected pregnancies.
How similar studies have performed: Other studies have explored treatments for FNAIT, but the specific use of nipocalimab in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant and an estimated gestational age from week 13 to 18 at visit 1 * 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 * 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 this trial is running
Birmingham, Alabama and 23 other locations
- 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)
- Advocate Children's Hospital — Park Ridge, Illinois, United States (Recruiting)
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Oregon Health And Science University — Portland, Oregon, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
- Medizinische Universitaet Graz — Graz, Austria (Recruiting)
- Medical University Vienna — Vienna, Austria (Recruiting)
- Universitaetsklinikum Giessen und Marburg GmbH — Giessen, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hanover, Germany (Recruiting)
- Universitatsklinikum Jena — Jena, Germany (Recruiting)
- Universitaetsklinikum Tuebingen — Tübingen, Germany (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Instytut Centrum Zdrowia Matki Polki — Lodz, Poland (Recruiting)
- Instytut Matki i Dziecka — Warsaw, Poland (Recruiting)
- Panstwowy Instytut Medyczny MSWiA w Warszawie — Warsaw, Poland (Recruiting)
- Birmingham Women's Hospital — Birmingham, United Kingdom (Recruiting)
- Liverpool Women's NHS Foundation Trust - Liverpool Women's Hospital — Liverpool, United Kingdom (Recruiting)
- Queen Charlotte's and Chelsea Hospital — London, United Kingdom (Recruiting)
- John Radcliffe Hospital — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.