RecruitingRare disease

Study on Nipocalimab for Reducing Risk of Fetal and Neonatal Alloimmune Thrombocytopenia in At-risk Pregnancies

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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), which can occur during pregnancy. FNAIT is a rare condition where the mother's immune system mistakenly attacks the baby's platelets, which are small blood cells that help with clotting. This can lead to low platelet counts in the baby, increasing the risk of bleeding. The study is testing a treatment called nipocalimab, which is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein. Nipocalimab is being compared to a placebo to see if it can reduce the risk of severe FNAIT in pregnancies that are considered at risk.

The purpose of the study is to evaluate whether nipocalimab is more effective than a placebo in reducing the risk of severe FNAIT. Participants in the study will receive either nipocalimab or a placebo, and the study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The study will follow the participants throughout their pregnancy and monitor the health of the baby up to the first week after birth. This will help determine if nipocalimab can safely and effectively reduce the risk of complications associated with FNAIT.

Throughout the study, the health of both the mother and the baby will be closely monitored. This includes regular check-ups and assessments to ensure the safety and well-being of both. The study aims to provide valuable information on the potential benefits of nipocalimab in managing FNAIT and improving outcomes for at-risk pregnancies. Participants will be contributing to important research that could lead to better treatment options for this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication, nipocalimab, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
Step 2
Initial assessment
An initial assessment will be conducted to ensure your health status is stable. This includes a physical examination, review of medical history, vital signs check, an ECG (a test that measures the electrical activity of the heart), and laboratory tests.
Step 3
Medication administration
If you are assigned to receive nipocalimab, it will be administered through an intravenous infusion. This means the medication will be given directly into a vein using a needle. The frequency and dosage will be determined by the study protocol and communicated to you by the study team.
Step 4
Ongoing monitoring
Throughout the study, regular monitoring will be conducted to assess your health and the effects of the medication. This may include additional physical exams, blood tests, and other necessary evaluations as determined by the study team.
Step 5
Completion of the study
At the end of the study period, a final assessment will be conducted to evaluate the outcomes. This will include checking the health of the newborn and measuring platelet counts at birth.

Who can join the trial?

5 criteria

Must be a female who is at least 18 years old.
Must be pregnant with an estimated gestational age (the age of the pregnancy) between Week 13 to 16 at the time of joining the study.
Must have had at least one previous pregnancy affected by FNAIT, which is a condition where the baby's platelet count is low, but none of the previous pregnancies should have had severe bleeding in the baby.
In the current pregnancy, the mother must have a specific antibody called anti-HPA-1a, and the baby must have a positive HPA-1a genotype, which is confirmed by a blood test from the mother.
Must be in stable health as determined by a doctor, based on a physical exam, medical history, vital signs, heart test (ECG), and lab tests done at the start of the study.

Who cannot join the trial?

3 criteria

Patients who are not female cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the vulnerable population selected for the study cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Universitaire De Lille
Lille, France
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruitingNot recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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 serious bleeding problems. Nipocalimab works by targeting and blocking certain proteins in the immune system that may contribute to this condition. The goal of using nipocalimab in this trial is to see if it can reduce the risk of severe FNAIT, making it safer for both the mother and the baby during pregnancy.

Nipocalimab

What is already known about the treatment

Nipocalimab – Nipocalimab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials to assess its effectiveness and safety in reducing the risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in pregnancies that are considered at risk. The main therapeutic indication for nipocalimab is to prevent severe cases of FNAIT, a condition where the immune system of a pregnant woman attacks the platelets of the fetus, leading to low platelet counts. At the molecular level, nipocalimab works by blocking certain immune responses that contribute to this condition. It is classified pharmacologically as an immunomodulatory agent, which means it helps regulate or modify the immune system's activity.

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. Platelets are crucial for blood clotting, and their deficiency can result in bleeding complications. The disease progresses as maternal antibodies cross the placenta and target fetal platelets, causing their destruction. This can lead to bleeding in the fetus or newborn, which may occur in utero or shortly after birth. The severity of the condition can vary, with some cases resulting in significant bleeding issues. Monitoring platelet levels is essential to understand the progression of the disease.