Evaluating nipocalimab for preventing fetal and neonatal alloimmune 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 assess the effectiveness of nipocalimab in comparison to a placebo for reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pregnant women with a history of FNAIT and specific genetic markers will be enrolled between 13 to 18 weeks of gestation. Participants will receive either nipocalimab or a placebo, and their outcomes will be monitored to determine the drug's efficacy in preventing complications associated with FNAIT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
* Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (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 (refer to the Investigator Brochure (IB))
* 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

• Semmelweis Egyetem
  Budapest, Hungary Recruiting
• Haukeland University Hospital
  Bergen, Norway Recruiting
• Oslo University Hospital HF Ulleval sykehus
  Oslo, Norway Recruiting
• Universitetssykehuset Nord-Norge HF
  Tromsø, Norway Recruiting
• St. Olavs Hospital
  Trondheim, Norway Recruiting
• Karolinska Universitetssjukhuset Huddinge
  Stockholm, Sweden Recruiting

Study contacts

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

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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.