RecruitingPHASE3INTERVENTIONAL

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

This research study is looking at a new drug called nipocalimab. It's for pregnant women who have had a baby before with a condition called Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). FNAIT happens when the mother's immune system attacks the baby's platelets, which are tiny blood cells that help stop bleeding. This can cause the baby to have very low platelet counts at birth. The study aims to find out if nipocalimab can reduce the risk of a baby developing severe FNAIT. Participants will either receive nipocalimab or a placebo (a dummy medicine) to compare their effects. This is a Phase 3 study, meaning it's a larger study to confirm the drug's effectiveness and safety before it can be potentially approved for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

11 Nov 2024

Estimated completion

05 Dec 2029

Thrombocytopenia, Neonatal Alloimmune

What is this study about?

This study is focused on a health problem called Fetal and Neonatal Alloimmune Thrombocytopenia, or FNAIT. For some pregnant women, their immune system can react to the baby's blood in a way that causes the baby's platelet count (cells that help blood clot) to drop very low. This can potentially lead to bleeding issues for the baby, sometimes even serious ones. While this study is open to women who have had a baby with FNAIT before, it specifically focuses on those whose previous babies did not have severe brain bleeds or other very serious bleeding problems.

Researchers are testing a new medicine called nipocalimab to see if it can help prevent severe FNAIT in these babies. Half the participants will receive nipocalimab, and the other half will receive a placebo, which looks like the real medicine but contains no active drug. This allows the researchers to fairly compare how well nipocalimab works against not receiving the active treatment.

The goal is to see if nipocalimab can safely reduce the chances of a new baby developing severe FNAIT. It's hoped that this study will provide important information that could help protect future babies from this condition.

Key takeaways

This study is for pregnant women with a history of FNAIT.
It aims to test if a new drug, nipocalimab, can prevent severe FNAIT in babies.
Participants will receive either nipocalimab or a placebo.
Regular health checks for both mother and baby are part of the study.
The study is a Phase 3 trial, designed to confirm effectiveness and safety.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

You might be able to join this study if you are pregnant, between 18 and 45 years old, and are 13 to 18 weeks pregnant. A key requirement is that you've had at least one previous pregnancy where the baby was diagnosed with FNAIT (meaning their platelet count was less than 150 at birth), but none of those babies had a brain bleed or severe bleeding. Also, your current baby must have a specific blood factor called HPA-1a, and your blood must show antibodies against it – this will be checked using a special blood test.

There are also reasons why you might not be able to join. For example, if you are pregnant with twins or more babies, or if you've had severe high blood pressure in a previous pregnancy. You also can't have certain heart conditions, known allergies to the study medicine, or problems with your immune system. If you're generally unwell or taking part in another drug trial, you wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant and between 13 and 18 weeks along?
Are you aged 18 to 45 years?
Have you previously had a baby with FNAIT, but without severe brain bleeds?
Has your current baby been confirmed to have the specific HPA-1a blood type, and do you have the corresponding antibodies?
Are you generally in good health?
Are you not pregnant with more than one baby (e.g., twins)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the study medicine, nipocalimab, or a placebo (a dummy medicine). You will have regular appointments and tests throughout your pregnancy to monitor your health and your baby's development. This will include physical examinations, blood tests, heart checks (ECG), and ultrasounds. After your baby is born, both you and your baby will continue to have follow-up visits to check your health and your baby's platelet counts and general well-being. The study will involve a series of visits over many months, covering your pregnancy and the period after your baby is born, up until a final follow-up appointment.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by reducing the risk of your baby developing severe FNAIT. However, as with any new medicine, there might be side effects or risks that we don't fully know yet. These will be carefully monitored by the study team. You will be told about any known risks before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitair Ziekenhuis Leuven
Verified postcode
Leuven, Belgium· Recruiting
Instituto de Medicina Integral Professor Fernando Figueira
Verified postcode
Recife, Brazil· Recruiting
Instituto D Or de Pesquisa e Ensino IDOR
Verified postcode
Rio de Janeiro, Brazil· Recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Verified postcode
São Paulo, Brazil· Recruiting
CHRU Lille
Verified postcode
Lille, France· Recruiting
Hopital trousseau- APHP
Verified postcode
Paris, France· Recruiting
Semmelweis Egyetem
Verified postcode
Budapest, Hungary· Recruiting
Sheba Medical Center
Verified postcode
Ramat Gan, Israel· Recruiting
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Verified postcode
Milan, Italy· Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Verified postcode
Rome, Italy· Recruiting
Haukeland University Hospital
Verified postcode
Bergen, Norway· Recruiting
Oslo University Hospital HF Ulleval sykehus
Verified postcode
Oslo, Norway· Recruiting

Common questions

What is FNAIT?

FNAIT (Fetal and Neonatal Alloimmune Thrombocytopenia) is a condition where a mother's immune system attacks her baby's platelets, leading to low platelet counts and a risk of bleeding problems in the newborn.

What is nipocalimab?

Nipocalimab is a new medicine being tested in this study to see if it can help prevent severe FNAIT in babies.

What is a placebo?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the medicine.

How long will the study last for me and my baby?

The study will involve regular visits throughout your pregnancy and after your baby is born, until a final follow-up appointment, which will be discussed in detail by the study team.

Can I leave the study if I change my mind?

Yes, taking part in this study is completely voluntary. You can decide to leave the study at any time without having to give a reason, and it won't affect your regular medical care.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.