Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
- Conditions
- Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)MedDRA version: 20.1Level: PTClassification code: 10075149Term: Neonatal alloimmune thrombocytopenia Class: 100000004850Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504307-88-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
Female, =18 years of age at the time of informed consent, Pregnant and an estimated GA (based on ultrasound dating) between Week 13 to 16 at randomization, Has a history of =1 prior pregnancy with FNAIT (including neonatal platelet count <150×109/L), with none of them affected by fetal/neonatal ICH or severe hemorrhage based on medical records, Current pregnancy with presence of maternal anti-HPA-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal DNA in maternal blood, Health status considered stable by the investigator on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening
Currently pregnant with multiple gestations (twins or more), History of severe preeclampsia in a previous pregnancy, History of severe FGR (EFW <3rd percentile) 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 IB)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the superiority of nipocalimab compared with placebo in reducing the risk of severe FNAIT;Secondary Objective: To evaluate the efficacy of nipocalimab compared with placebo on FNAIT-related thrombocytopenia, To evaluate the efficacy of nipocalimab compared with placebo in reducing the risk of FNAIT-related bleeding;Primary end point(s): Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10?/l in a fetus/neonate.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Platelet count at birth in a neonate;Secondary end point(s):Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate