RecruitingRare disease

Study of Nipocalimab or IVIG for Pregnant Women at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). This is a rare condition that can occur during pregnancy, where the mother's immune system mistakenly attacks the baby's platelets, which are cells that help with blood clotting. The study will explore the effectiveness of two treatments: nipocalimab, which is a type of protein-based medication given through an injection, and human normal immunoglobulin (IV), also known as IVIG, which is a blood-derived product also administered through an injection.

The purpose of the study is to assess how well these treatments work in reducing the risk of severe FNAIT. Participants in the study will be randomly assigned to receive either nipocalimab or IVIG. The study will be conducted over a period of time, with regular monitoring to ensure the safety and health of both the mother and the baby. The treatment period for nipocalimab is up to 29 weeks, while for IVIG, it is up to 30 weeks.

Throughout the study, participants will receive regular check-ups and monitoring to track the health of the fetus and the mother. The study aims to determine if these treatments can help prevent severe bleeding or low platelet counts in the baby, both before and shortly after birth. This research is important for finding better ways to manage and treat FNAIT, potentially improving outcomes for affected pregnancies.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your health status will be assessed through a physical examination, medical history review, vital signs check, and laboratory tests.
Your pregnancy will be confirmed to be between weeks 13 to 16, and the presence of specific antibodies will be verified through a blood test.
Step 2
Randomization
You will be randomly assigned to receive either nipocalimab or human normal immunoglobulin (IV). This process ensures that each participant has an equal chance of receiving either treatment.
Step 3
Treatment administration
If assigned to nipocalimab, you will receive it through an intravenous infusion. The frequency and dosage will be determined by the study protocol.
If assigned to human normal immunoglobulin (IV), you will also receive it through an intravenous infusion. The frequency and dosage will be determined by the study protocol.
Step 4
Regular follow-up visits
You will attend regular follow-up visits to monitor your health and the progress of your pregnancy. These visits will include physical examinations, blood tests, and other necessary assessments.
The study team will closely monitor for any adverse effects or complications.
Step 5
End of treatment
The treatment will continue until the end of your pregnancy or as specified by the study protocol.
You will have a final assessment to evaluate the outcomes of the treatment on your health and the health of your baby.
Step 6
Post-birth follow-up
After the birth of your baby, there will be a follow-up period to monitor the health of your newborn. This includes checking for any bleeding issues or low platelet counts.
The study team will provide guidance and support during this period.

Who can join the trial?

4 criteria

Must be female and at least 18 years old at the time of giving consent to participate.
Must be pregnant with an estimated gestational age (GA) between Week 13 to 16 at the first visit. Screening can start at GA Week 8.
Must have a current pregnancy with the presence of specific antibodies called anti-HPA-1a and/or anti-HPA-5b in the mother's blood, and the fetus must have a positive result for the HPA-1a and/or HPA-5b genotype, confirmed by a test using the mother's blood.
Must have a health status considered stable by the study doctor, based on a physical exam, medical history, vital signs, heart test (12-lead ECG), and lab tests done at the start of the study.

Who cannot join the trial?

3 criteria

Participants must be **female**. This means only women can join the study.
Participants must be within a certain **age range**. This means only women of specific ages can join.
Participants must not be part of a **vulnerable population**. This means people who might need special care or protection cannot join.

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Verified sites

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

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Investigated drugs

Nipocalimab
is a medication being studied for its potential to help pregnant women who are at risk of a condition called Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). This condition can cause low platelet counts in the unborn baby, which can lead to bleeding problems. Nipocalimab works by targeting specific proteins in the immune system to prevent the mother's immune system from attacking the baby's platelets. This medication is being tested to see if it can reduce the risk of severe complications from FNAIT.
IVIG
, or Intravenous Immunoglobulin, is a therapy that involves giving a patient a mixture of antibodies through a vein. These antibodies are proteins that help the immune system fight infections. In this clinical trial, IVIG is being used to see if it can help protect the unborn baby from the mother's immune system, which might mistakenly attack the baby's platelets in cases of FNAIT. The goal is to see if IVIG can reduce the risk of severe bleeding problems in the baby.

What is already known about the treatment

Nipocalimab – Nipocalimab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main therapeutic indication for Nipocalimab is to reduce the risk of severe Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), a condition where a mother's immune system attacks the platelets of the fetus or newborn. At the molecular level, Nipocalimab works by blocking certain immune system proteins that are involved in this harmful response. It is classified pharmacologically as a monoclonal antibody, which is a type of protein designed to target specific molecules in the body.

Investigated diseases

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) – This condition occurs when the mother's immune system mistakenly attacks the platelets of the fetus or newborn, leading to a low platelet count. It is caused by incompatibility between the mother's and the baby's platelet antigens. The disease can lead to bleeding complications in the fetus or newborn, as platelets are essential for blood clotting. The condition may develop during pregnancy and can affect the fetus in utero. After birth, the newborn may continue to experience low platelet levels. The severity of the condition can vary, with some cases being mild and others more severe.