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New treatment option for Thrombocytopenia, Neonatal Alloimmune
Official title A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
ClinicalTrials.gov ID: NCT06449651
What this study is testing
What is Nipocalimab?
Nipocalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thrombocytopenia, neonatal alloimmune.
Also referred to as JNJ-80202135, JNJ-86507083.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by...
- Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and...
- For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last...
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Recife, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Lille, France
- Paris, France
- Budapest, Hungary
- Ramat Gan, Israel
- Milan, Italy
- Rome, Italy
- Bergen, Norway
- Oslo, Norway
- Tromsø, Norway
- Trondheim, Norway
- Košice, Slovakia
- Martin, Slovakia
- Nové Zámky, Slovakia
- Ljubljana, Slovenia
- Seville, Spain
- Stockholm, Sweden
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Recife, Brazil; Rio de Janeiro, Brazil; São Paulo, Brazil; Lille, France; Paris, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.